Trial Outcomes & Findings for MT2017-45: CAR-T Cell Therapy for Heme Malignancies (NCT NCT03642626)
NCT ID: NCT03642626
Last Updated: 2026-01-23
Results Overview
ORR defined by complete response + partial response by Lugano
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Day 100
Results posted on
2026-01-23
Participant Flow
Participant milestones
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
YESCARTA: CD19-directed genetically modified autologous T cell immunotherapy
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
26
|
44
|
30
|
7
|
13
|
20
|
10
|
|
Overall Study
COMPLETED
|
26
|
44
|
30
|
7
|
13
|
20
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MT2017-45: CAR-T Cell Therapy for Heme Malignancies
Baseline characteristics by cohort
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 Participants
YESCARTA: CD19-directed genetically modified autologous T cell immunotherapy
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=30 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 Participants
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
17 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
17 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=270 Participants
|
33 Participants
n=4 Participants
|
14 Participants
n=9 Participants
|
3 Participants
n=220 Participants
|
1 Participants
n=3 Participants
|
6 Participants
n=18 Participants
|
10 Participants
n=2259 Participants
|
76 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=270 Participants
|
11 Participants
n=4 Participants
|
16 Participants
n=9 Participants
|
4 Participants
n=220 Participants
|
12 Participants
n=3 Participants
|
14 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
57 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=270 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=9 Participants
|
2 Participants
n=220 Participants
|
4 Participants
n=3 Participants
|
10 Participants
n=18 Participants
|
6 Participants
n=2259 Participants
|
58 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=270 Participants
|
29 Participants
n=4 Participants
|
15 Participants
n=9 Participants
|
5 Participants
n=220 Participants
|
9 Participants
n=3 Participants
|
10 Participants
n=18 Participants
|
4 Participants
n=2259 Participants
|
92 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
2 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=270 Participants
|
43 Participants
n=4 Participants
|
29 Participants
n=9 Participants
|
7 Participants
n=220 Participants
|
11 Participants
n=3 Participants
|
19 Participants
n=18 Participants
|
8 Participants
n=2259 Participants
|
142 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
6 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
3 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
3 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=270 Participants
|
40 Participants
n=4 Participants
|
26 Participants
n=9 Participants
|
5 Participants
n=220 Participants
|
11 Participants
n=3 Participants
|
18 Participants
n=18 Participants
|
8 Participants
n=2259 Participants
|
133 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=220 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=2259 Participants
|
1 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=9 Participants
|
1 Participants
n=220 Participants
|
2 Participants
n=3 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=2259 Participants
|
9 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=270 Participants
|
44 participants
n=4 Participants
|
30 participants
n=9 Participants
|
7 participants
n=220 Participants
|
13 participants
n=3 Participants
|
20 participants
n=18 Participants
|
10 participants
n=2259 Participants
|
150 participants
n=1 Participants
|
PRIMARY outcome
Timeframe: Day 100ORR defined by complete response + partial response by Lugano
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=44 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=30 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Arms B & C&D& E&F: Overall Response Rate (ORR)
|
77.3 Percentage of participants
Interval 63.0 to 87.2
|
61.3 Percentage of participants
Interval 43.8 to 76.3
|
100 Percentage of participants
Interval 59.0 to 100.0
|
69.2 Percentage of participants
Interval 42.4 to 87.3
|
35 Percentage of participants
Interval 18.1 to 56.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 28Percentage of patients with MRD-negative Complete Response CR (or CRi)
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=13 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Arm A & E: MRD-negative CR (or CRi)
|
88.5 Percentage of participants
Interval 71.0 to 96.0
|
100 Percentage of participants
Interval 75.3 to 100.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28Percentage of patients developing grade 3 or 4 ICANS
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=30 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 Participants
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Percentage of Patients Developing Grade 3 or 4 ICANS
|
4 Percentage of participants
Interval 0.0 to 21.0
|
20.5 Percentage of participants
Interval 11.1 to 34.5
|
3.3 Percentage of participants
Interval 0.0 to 17.2
|
42.8 Percentage of participants
Interval 15.8 to 75.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
10 Percentage of participants
Interval 3.1 to 32.8
|
10 Percentage of participants
Interval 1.8 to 40.4
|
SECONDARY outcome
Timeframe: Day 28Incidence of treatment related mortality (in absence of disease relapse/progression)
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=30 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 Participants
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Treatment Related Mortality (TRM)
|
0 Percentage of participants
Interval 0.0 to 100.0
|
2.3 Percentage of participants
Interval 0.0 to 7.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 100Incidence of treatment related mortality (in absence of disease relapse/progression)
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=30 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 Participants
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Treatment Related Mortality (TRM)
|
0 Percentage of participants
Interval 0.0 to 100.0
|
2.3 Percentage of participants
Interval 0.0 to 7.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 YearIncidence of treatment related mortality (in absence of disease relapse/progression)
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=30 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 Participants
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Treatment Related Mortality (TRM)
|
0 Percentage of participants
Interval 0.0 to 100.0
|
7 Percentage of participants
Interval 0.0 to 14.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
14 Percentage of participants
Interval 0.0 to 38.0
|
15 Percentage of participants
Interval 0.0 to 34.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 yearIncidence of Relapse-free Survival (RFS)
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=30 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 Participants
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Relapse-free Survival (RFS)
|
46 Percentage of participants
Interval 25.0 to 68.0
|
25 Percentage of participants
Interval 12.0 to 38.0
|
47 Percentage of participants
Interval 28.0 to 65.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
28 Percentage of participants
Interval 2.0 to 44.0
|
55 Percentage of participants
Interval 35.0 to 75.0
|
10 Percentage of participants
Interval 0.0 to 28.0
|
SECONDARY outcome
Timeframe: 1 Year post treatmentIncidence of event-free survival (EFS) from the date of the CAR-T infusion through 1 year post treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearIncidence of Overall Survival (OS) from the date of the CAR-T infusion through the date of patient death for any reason.
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=30 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 Participants
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
88 Percentage of participants
Interval 63.0 to 96.0
|
86 Percentage of participants
Interval 72.0 to 94.0
|
77 Percentage of participants
Interval 56.0 to 88.0
|
86 Percentage of participants
Interval 33.0 to 98.0
|
69 Percentage of participants
Interval 37.0 to 87.0
|
90 Percentage of participants
Interval 66.0 to 97.0
|
100 Percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Day 28Percentage of patients with grade 3 or 4 targeted toxicity of CRS and/or neurotoxicity
Outcome measures
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=23 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 Participants
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=30 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=7 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=13 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 Participants
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 Participants
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Overall Toxicity
|
21.7 Percentage of participants
Interval 9.7 to 41.9
|
2.3 Percentage of participants
Interval 0.0 to 11.8
|
0 Percentage of participants
Interval 0.0 to 100.0
|
14.3 Percentage of participants
Interval 2.6 to 51.3
|
0 Percentage of participants
Interval 0.0 to 100.0
|
0 Percentage of participants
Interval 0.0 to 100.0
|
10 Percentage of participants
Interval 1.8 to 40.4
|
Adverse Events
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 3 deaths
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ARM A: Refractory/Relapsed B-cell Acute Lymphoblastic Leukemia (ALL)
n=26 participants at risk
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 30mg/m2 4 doses: 30 mg/m2 IV daily for 4 doses
Cyclophosphamide 500 mg/m2; 2 doses: 500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
|
ARM B: Yescarta for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=44 participants at risk
YESCARTA: CD19-directed genetically modified autologous T cell immunotherapy
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
|
ARM C: Kymriah for Refractory Diffuse Large B Cell Lymphoma (DLBCL)
n=30 participants at risk
KYMRIAH: FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Cyclophosphamide 250 mg/m2; 3 days: 250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
|
Arm D: Tecartus CAR-T Product for Mantle Cell Leukemia (MCL)
n=7 participants at risk
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
|
Arm E: Breyanzi for Relapsed or Refractory Large B-cell Lymphoma (RLBCL)
n=13 participants at risk
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Breyanzi Injectable Product: Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.
|
Arm F: Abecma for Relapsed or Refractory Multiple Myeloma
n=20 participants at risk
Fludarabine 30mg/m2 3 doses: 30 mg/m2 IV daily for 3 doses
Cyclophosphamide 500 mg/m2; 3 doses: 500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
Abecma, Intravenous Suspension: Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.
|
Arm G: Tecartus B-cell Acute Lymphoblastic Leukemia (ALL)
n=10 participants at risk
Fludarabine 25mg/m2 3 days: 25 mg/m2 i.v. daily for 3 days
Tecartus: TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
Cyclophosphamide 900 mg/m2; 1 day: Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/26 • 1 year
|
2.3%
1/44 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
0.00%
0/7 • 1 year
|
0.00%
0/13 • 1 year
|
0.00%
0/20 • 1 year
|
0.00%
0/10 • 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place