Trial Outcomes & Findings for Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer (NCT NCT04111510)
NCT ID: NCT04111510
Last Updated: 2024-11-21
Results Overview
To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer (TNBC) patients by determining the objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the Investigator. Upon results entry, the time frame was updated to reflect the latest time point that a participant was assessed for ORR in the study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2024-11-21
Participant Flow
Participant milestones
| Measure |
LN-145
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
LN-145
n=6 Participants
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsTo evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer (TNBC) patients by determining the objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the Investigator. Upon results entry, the time frame was updated to reflect the latest time point that a participant was assessed for ORR in the study.
Outcome measures
| Measure |
LN-145
n=6 Participants
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Objective Response Rate (ORR)
complete response (CR)
|
0 Participants
|
|
Objective Response Rate (ORR)
partial response (PR)
|
1 Participants
|
|
Objective Response Rate (ORR)
stable disease (SD)
|
1 Participants
|
|
Objective Response Rate (ORR)
progressive disease (PD)
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsTo characterize the safety profile of tumor infiltrating lymphocytes (TIL) as a single therapy in Metastatic Triple Negative Breast Cancer patients as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs). Incidence is presented as a count of participants that experienced at least 1 TEAE of Grade ≥ 3.
Outcome measures
| Measure |
LN-145
n=6 Participants
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Safety Profile
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Only assessed in participants that had a PR. Only one participant had a PR. Method of dispersion was not collected as was only one participant.
To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer patients in participants that have a clinical response (either partial response (PR) or complete response (CR)) using duration of response (DOR), using RECIST 1.1, as assessed by the Investigator will be used.
Outcome measures
| Measure |
LN-145
n=1 Participants
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Duration of Response (DOR) in Days
|
79 days
|
SECONDARY outcome
Timeframe: Up to 3 yearsTo evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer patients using disease control rate (DCR), using RECIST 1.1, as assessed by the Investigator will be used. Percentage of patients whose disease shrinks or remains stable over a certain time period.
Outcome measures
| Measure |
LN-145
n=6 Participants
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Disease Control Rate (DCR)
|
66.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsTo evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer patients, median progression-free survival (PFS) days, using RECIST 1.1, as assessed by the Investigator will be used.
Outcome measures
| Measure |
LN-145
n=6 Participants
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Progression-free Survival (PFS)
|
46.5 days
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsTo evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast patients overall survival (OS) median days will be used.
Outcome measures
| Measure |
LN-145
n=6 Participants
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Overall Survival (OS)
|
156.5 days
Standard Deviation 66.8
|
SECONDARY outcome
Timeframe: Up to 3 yearsTo evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast patients complete response, using RECIST 1.1, as assessed by the Investigator will be used. The number of participants with a complete response.
Outcome measures
| Measure |
LN-145
n=6 Participants
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Complete Response (CR)
|
0 Participants
|
Adverse Events
LN-145
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
LN-145
n=6 participants at risk
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Investigations
Blood bilirubin increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
LN-145
n=6 participants at risk
LN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Tumor infiltrating lymphocytes (TIL) LN-145: The TIL autologous therapy with LN-145 is comprised of the following steps:
1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
4/6 • Number of events 8 • Up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
2/6 • Number of events 4 • Up to 3 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
4/6 • Number of events 5 • Up to 3 years
|
|
Blood and lymphatic system disorders
White blood cell count decreased
|
66.7%
4/6 • Number of events 10 • Up to 3 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
66.7%
4/6 • Number of events 15 • Up to 3 years
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
83.3%
5/6 • Number of events 5 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
83.3%
5/6 • Number of events 7 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • Number of events 7 • Up to 3 years
|
|
Gastrointestinal disorders
Loss of appetite
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Intermittent Emesis
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
General disorders
Fever
|
83.3%
5/6 • Number of events 7 • Up to 3 years
|
|
General disorders
Chills
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
|
General disorders
Rigors
|
66.7%
4/6 • Number of events 5 • Up to 3 years
|
|
General disorders
Pain
|
33.3%
2/6 • Number of events 5 • Up to 3 years
|
|
General disorders
Weight Gain
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Infection
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
General disorders
Dehydration
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
General disorders
Hair loss
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
4/6 • Number of events 6 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Aspartate aminotransferase increased
|
50.0%
3/6 • Number of events 4 • Up to 3 years
|
|
Metabolism and nutrition disorders
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Blood bilirubin increased
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
CPK increased
|
16.7%
1/6 • Number of events 2 • Up to 3 years
|
|
Metabolism and nutrition disorders
Creatinine increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Lipase increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Serum amylase increased
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
50.0%
3/6 • Number of events 3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
3/6 • Number of events 6 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
1/6 • Number of events 3 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Headache
|
66.7%
4/6 • Number of events 6 • Up to 3 years
|
|
Nervous system disorders
Confusion
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Hand tremor
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Psychiatric disorders
Anxiety
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • Number of events 2 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
General edema
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Thrombocytopenia
|
66.7%
4/6 • Number of events 11 • Up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Cardiac disorders
Bradycardia
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Eye disorders
Eye pain
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • Number of events 1 • Up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place