Trial Outcomes & Findings for Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma (NCT NCT03610490)
NCT ID: NCT03610490
Last Updated: 2025-04-17
Results Overview
The ORR is derived as the sum of the number of patients with a confirmed CR or partial response (PR) divided by the number of patients in the All-Treated analysis set x 100%.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Through 4 years
Results posted on
2025-04-17
Participant Flow
The study was activated on 08/17/2018 and the first participant was registered on study 10/16/2018. The study was closed to new patient entry on 04/02/2021 and the study was completed on 08/21/2024. All recruitments were done in a medical clinic setting.
Participant milestones
| Measure |
Autologous TIL
Lymphodepletion therapy followed by autologous expanded TIL infusion then high dose IL-2 infusion
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Autologous Tumor Infiltrating Lymphocytes MDA-TIL in Treating Patients With Recurrent or Refractory Ovarian Cancer, Colorectal Cancer, or Pancreatic Ductal Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Autologous TIL
n=16 Participants
Lymphodepletion therapy followed by autologous expanded TIL infusion then high dose IL-2 infusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 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
|
1 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
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through 4 yearsThe ORR is derived as the sum of the number of patients with a confirmed CR or partial response (PR) divided by the number of patients in the All-Treated analysis set x 100%.
Outcome measures
| Measure |
Autologous TIL
n=16 Participants
Lymphodepletion therapy followed by autologous expanded TIL infusion then high dose IL-2 infusion
|
|---|---|
|
Objective Response Rate (ORR) in Participants With Ovarian Cancer (OVCA), PDAC (Pancreatic Cancer), and Colorectal Cancers (CRC) According to RECIST v1.1 in Subjects With Ovarian Cancer (OVCA), PDAC (Pancreatic Cancer), and Colorectal Cancers (CRC)
|
0 Precentage of Participants
Interval 0.0 to 21.0
|
SECONDARY outcome
Timeframe: 6 weeks, 12 weeksParticipants will be evaluated at 6 and 12 weeks for response.
Outcome measures
| Measure |
Autologous TIL
n=16 Participants
Lymphodepletion therapy followed by autologous expanded TIL infusion then high dose IL-2 infusion
|
|---|---|
|
Number of Participants With Stable Disease
Stable Disease at 6 weeks
|
10 participants
|
|
Number of Participants With Stable Disease
Stable Disease at 12 weeks
|
5 participants
|
SECONDARY outcome
Timeframe: 44.8 monthsOutcome measures
| Measure |
Autologous TIL
n=16 Participants
Lymphodepletion therapy followed by autologous expanded TIL infusion then high dose IL-2 infusion
|
|---|---|
|
Progression-free Survival (PFS) and Overall Survival (OS)
PFS
|
2.53 months
Interval 1.54 to 4.11
|
|
Progression-free Survival (PFS) and Overall Survival (OS)
OS
|
18.86 months
Interval 4.86 to
Not reached.
|
Adverse Events
Autologous TIL
Serious events: 1 serious events
Other events: 16 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Autologous TIL
n=16 participants at risk
Lymphodepletion therapy followed by autologous expanded TIL infusion then high dose IL-2 infusion
|
|---|---|
|
Hepatobiliary disorders
Hepatobiliary disorder - drug induced liver toxicity
|
6.2%
1/16 • Up to 4 years
|
Other adverse events
| Measure |
Autologous TIL
n=16 participants at risk
Lymphodepletion therapy followed by autologous expanded TIL infusion then high dose IL-2 infusion
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Investigations
Alanine aminotransferase increased
|
18.8%
3/16 • Number of events 6 • Up to 4 years
|
|
Investigations
Alkaline phosphatase increased
|
12.5%
2/16 • Number of events 2 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.8%
3/16 • Number of events 3 • Up to 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
56.2%
9/16 • Number of events 11 • Up to 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
50.0%
8/16 • Number of events 8 • Up to 4 years
|
|
Gastrointestinal disorders
Ascites
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
4/16 • Number of events 6 • Up to 4 years
|
|
Gastrointestinal disorders
Bloating
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Vascular disorders
Capillary leak syndrome
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Cheilitis
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
General disorders
Chills
|
87.5%
14/16 • Number of events 15 • Up to 4 years
|
|
Psychiatric disorders
Confusion
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Constipation
|
43.8%
7/16 • Number of events 7 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
2/16 • Number of events 2 • Up to 4 years
|
|
Investigations
CPK increased
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
6/16 • Number of events 6 • Up to 4 years
|
|
Nervous system disorders
Dizziness
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
75.0%
12/16 • Number of events 13 • Up to 4 years
|
|
General disorders
Edema limbs
|
37.5%
6/16 • Number of events 6 • Up to 4 years
|
|
General disorders
Edema trunk
|
12.5%
2/16 • Number of events 2 • Up to 4 years
|
|
General disorders
Fatigue
|
87.5%
14/16 • Number of events 20 • Up to 4 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
12.5%
2/16 • Number of events 2 • Up to 4 years
|
|
General disorders
Fever
|
37.5%
6/16 • Number of events 6 • Up to 4 years
|
|
Vascular disorders
Flushing
|
18.8%
3/16 • Number of events 3 • Up to 4 years
|
|
General disorders
General disorders - fluid overload
|
25.0%
4/16 • Number of events 4 • Up to 4 years
|
|
General disorders
General disorders - fluid retention
|
18.8%
3/16 • Number of events 3 • Up to 4 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
12.5%
2/16 • Number of events 2 • Up to 4 years
|
|
Nervous system disorders
Headache
|
37.5%
6/16 • Number of events 6 • Up to 4 years
|
|
Vascular disorders
Hot flashes
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
2/16 • Number of events 2 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
4/16 • Number of events 4 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.8%
3/16 • Number of events 5 • Up to 4 years
|
|
Vascular disorders
Hypotension
|
12.5%
2/16 • Number of events 2 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
31.2%
5/16 • Number of events 5 • Up to 4 years
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Investigations
Lymphocyte count decreased
|
12.5%
2/16 • Number of events 4 • Up to 4 years
|
|
Gastrointestinal disorders
Mucositis oral
|
12.5%
2/16 • Number of events 2 • Up to 4 years
|
|
Gastrointestinal disorders
Nausea
|
75.0%
12/16 • Number of events 12 • Up to 4 years
|
|
Investigations
Neutrophil count decreased
|
31.2%
5/16 • Number of events 7 • Up to 4 years
|
|
Investigations
Platelet count decreased
|
81.2%
13/16 • Number of events 18 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
4/16 • Number of events 4 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
4/16 • Number of events 4 • Up to 4 years
|
|
Cardiac disorders
Sinus tachycardia
|
37.5%
6/16 • Number of events 6 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin disorder - other, macular rash
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Skin and subcutaneous tissue disorders
Skin disorder - other, erythema
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Vascular disorders
Vascular disorders - Other, fluid overload
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Gastrointestinal disorders
Vomiting
|
43.8%
7/16 • Number of events 7 • Up to 4 years
|
|
Investigations
Weight gain
|
37.5%
6/16 • Number of events 6 • Up to 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
|
Investigations
White blood cell decreased
|
6.2%
1/16 • Number of events 1 • Up to 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place