Trial Outcomes & Findings for Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors (NCT NCT03991741)
NCT ID: NCT03991741
Last Updated: 2025-07-03
Results Overview
Dose Limiting Toxicity (DLT)
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
3 participants
Primary outcome timeframe
2 months
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
Solid Tumor
Solid tumor
Autologous Tumor Infiltrating Lymphocytes: Autologous TILs
High-Dose Interleukin 2: 720,000 IU/kg every 8 hours for up to 15 doses
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors
Baseline characteristics by cohort
| Measure |
Solid Tumor
n=3 Participants
Solid tumor
Autologous Tumor Infiltrating Lymphocytes: Autologous TILs
High-Dose Interleukin 2: 720,000 IU/kg every 8 hours for up to 15 doses
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 monthsDose Limiting Toxicity (DLT)
Outcome measures
| Measure |
Solid Tumor
n=3 Participants
Solid tumor
Autologous Tumor Infiltrating Lymphocytes: Autologous TILs
High-Dose Interleukin 2: 720,000 IU/kg every 8 hours for up to 15 doses
|
|---|---|
|
Dose Limiting Toxicity
Blood and Lymphatic System Disorders
|
1 Participants
|
|
Dose Limiting Toxicity
Immune System Disorders, Renal and Urinary Disorders
|
1 Participants
|
|
Dose Limiting Toxicity
Infections and Infestations, Endocrine Disorders, Metabolism and Nutrition Disorders, Investigations
|
1 Participants
|
Adverse Events
Solid Tumor
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Solid Tumor
n=3 participants at risk
Solid tumor
Autologous Tumor Infiltrating Lymphocytes: Autologous TILs
High-Dose Interleukin 2: 720,000 IU/kg every 8 hours for up to 15 doses
|
|---|---|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Lung infection
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • 2 months
|
Other adverse events
| Measure |
Solid Tumor
n=3 participants at risk
Solid tumor
Autologous Tumor Infiltrating Lymphocytes: Autologous TILs
High-Dose Interleukin 2: 720,000 IU/kg every 8 hours for up to 15 doses
|
|---|---|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
1/3 • Number of events 2 • 2 months
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Psychiatric disorders
Hallucinations
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 3 • 2 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
3/3 • Number of events 3 • 2 months
|
|
Cardiac disorders
Pericardial effusion
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Endocrine disorders
Adrenal insufficiency
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Colitis
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • Number of events 2 • 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 4 • 2 months
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Dysphagia
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Gastroesophageal re ux disease
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Mucositis oral
|
33.3%
1/3 • Number of events 2 • 2 months
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • Number of events 3 • 2 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 3 • 2 months
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
General disorders
Localized edema
|
33.3%
1/3 • Number of events 2 • 2 months
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Immune system disorders
Cytokine release syndrome
|
66.7%
2/3 • Number of events 5 • 2 months
|
|
Infections and infestations
Bacteremia
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Infections and infestations
Lung infection
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Infections and infestations
Sepsis
|
66.7%
2/3 • Number of events 2 • 2 months
|
|
Investigations
Alanine aminotransferase increased
|
66.7%
2/3 • Number of events 2 • 2 months
|
|
Investigations
Alkaline phosphatase increased
|
66.7%
2/3 • Number of events 2 • 2 months
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 2 • 2 months
|
|
Investigations
Blood bilirubin increased
|
66.7%
2/3 • Number of events 2 • 2 months
|
|
Investigations
Neutrophil count decreased
|
66.7%
2/3 • Number of events 2 • 2 months
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Number of events 3 • 2 months
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • Number of events 2 • 2 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 1 • 2 months
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • 2 months
|
Additional Information
Gregory Daniels, MD, PhD
University of California, San Diego
Phone: (858) 822-5354
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place