Trial Outcomes & Findings for QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML (NCT NCT03050216)
NCT ID: NCT03050216
Last Updated: 2023-07-18
Results Overview
To estimate the rate of complete remission with incomplete platelet recovery (CRp) - defined as leukemic clearance and neutrophil recovery without platelet recovery - by day 42 after the infusion of CD3/CD19 depleted, ALT-803 stimulated, donor NK cells and subcutaneous ALT-803 given after a non-myeloablative preparative regimen for the treatment of refractory or released acute myelogenous leukemia (AML)
COMPLETED
PHASE2
8 participants
Day 42 post NK cell infusion
2023-07-18
Participant Flow
Participant milestones
| Measure |
Cy, FLU, Haplo NK and ALT-803
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
QUILT-3.033: Haplo NK With SQ ALT-803 for Adults With Relapsed or Refractory AML
Baseline characteristics by cohort
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=8 Participants
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Day 42 post NK cell infusionPopulation: One patient died after receiving 2 days of chemotherapy and never received any elements of research, NK cells or ALT-803. So only 7 participants' data were analyzed
To estimate the rate of complete remission with incomplete platelet recovery (CRp) - defined as leukemic clearance and neutrophil recovery without platelet recovery - by day 42 after the infusion of CD3/CD19 depleted, ALT-803 stimulated, donor NK cells and subcutaneous ALT-803 given after a non-myeloablative preparative regimen for the treatment of refractory or released acute myelogenous leukemia (AML)
Outcome measures
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=7 Participants
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Number of Participants With Complete Remission With or Without Incomplete Platelet Recovery
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 14 post NK cell infusionPopulation: One patient died after receiving 2 days of chemotherapy and never received any elements of research, NK cells or ALT-803. So only 7 participants' data were analyzed
Number of patients with successful in vivo NK-cell expansion which is defined by measuring an absolute circulating donor-derived NK cell count of ≥100 cells/μl in patient's peripheral blood.
Outcome measures
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=7 Participants
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Incidence of in Vivo Expansion ≥100 of Donor Derived NK Cells Per /μl Blood
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0Population: One patient died after receiving 2 days of chemotherapy and never received any elements of research, NK cells or ALT-803. So only 7 participants' data were analyzed
Toxicity will be classified and graded according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE)
Outcome measures
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=7 Participants
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Number of Participants Experiencing ALT-803 Associated Toxicity
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 5Population: One patient died after receiving 2 days of chemotherapy and never received any elements of research, NK cells or ALT-803. So only 7 participants' data were analyzed
Toxicity will be classified and graded according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE)
Outcome measures
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=7 Participants
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Number of Participants Experiencing ALT-803 Associated Toxicity
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 7Population: One patient died after receiving 2 days of chemotherapy and never received any elements of research, NK cells or ALT-803. So only 7 participants' data were analyzed
Toxicity will be classified and graded according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE)
Outcome measures
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=7 Participants
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Number of Participants Experiencing ALT-803 Associated Toxicity
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 10Population: One patient died after receiving 2 days of chemotherapy and never received any elements of research, NK cells or ALT-803. So only 7 participants' data were analyzed
Toxicity will be classified and graded according to NCI's Common Terminology Criteria for Adverse Events V 4.0 (CTCAE)
Outcome measures
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=7 Participants
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Number of Participants Experiencing ALT-803 Associated Toxicity
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 months post-therapyPopulation: One patient died after receiving 2 days of chemotherapy and never received any elements of research, NK cells or ALT-803. So only 7 participants' data were analyzed
To evaluate the safety of the therapy as measured by rate of treatment related mortality (TRM) at 6 months
Outcome measures
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=7 Participants
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Number of Participants With Treatment Related Mortality
|
6 Participants
|
Adverse Events
Cy, FLU, Haplo NK and ALT-803
Serious adverse events
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=8 participants at risk
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia - Changed to levaquin and micafungin
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart failure
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Infections and infestations
Lung infection
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
62.5%
5/8 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
12.5%
1/8 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Cy, FLU, Haplo NK and ALT-803
n=8 participants at risk
Fludarabine 25 mg/m2 x 5 days start Day -6 ; Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4 ; The Alt-803 stimulated NK cell enriched product on Day 0 followed by ALT-803 at 10 mcg/kg subcutaneously on Day 0, Day 5 and Day 10
|
|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
4/8 • Number of events 6 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oral pain
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
General disorders
Chills
|
87.5%
7/8 • Number of events 11 • 1 year
|
|
General disorders
Fatigue
|
50.0%
4/8 • Number of events 7 • 1 year
|
|
General disorders
Fever
|
62.5%
5/8 • Number of events 17 • 1 year
|
|
General disorders
Injection site reaction
|
87.5%
7/8 • Number of events 24 • 1 year
|
|
General disorders
Pain
|
25.0%
2/8 • Number of events 4 • 1 year
|
|
General disorders
Infusion related reaction
|
37.5%
3/8 • Number of events 3 • 1 year
|
|
Infections and infestations
Clostridium Difficile Infection
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Investigations
Blood bilirubin increased
|
12.5%
1/8 • Number of events 3 • 1 year
|
|
Investigations
Urine output decreased
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
1/8 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Nervous system disorders
Dizziness
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Nervous system disorders
Headache
|
75.0%
6/8 • Number of events 12 • 1 year
|
|
Nervous system disorders
Nervous system disorders - Other
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
1/8 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
25.0%
2/8 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.5%
1/8 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
25.0%
2/8 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypertension
|
50.0%
4/8 • Number of events 14 • 1 year
|
|
Vascular disorders
Hypotension
|
50.0%
4/8 • Number of events 6 • 1 year
|
Additional Information
Dr.Claudio G. Brunstein MD, PhD
Masonic Cancer Center, University of Minnesota
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place