← Back to Search

CAR T-cell Therapy

Immunotherapy with TIL for Cancer

Phase 2

Recruiting

Led By Steven A Rosenberg, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 72 years

Measurable metastatic cancer of specific types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including neuroendocrine tumors

Must not have

Active systemic infections, coagulation disorders, or any other active or uncompensated major medical illnesses

Known FEV1 less than or equal to 50%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new experimental therapy to see if it can cause tumors to shrink in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. The therapy involves taking white blood cells from patients' tumors, growing them in the laboratory, and then giving the cells back to the patient.

Who is the study for?

Adults aged 18-72 with certain types of metastatic cancer (digestive tract, breast, ovarian/endometrial, etc.) who haven't responded to standard treatments. Participants must not have HIV or hepatitis, agree to birth control and testing if applicable, and be in relatively good health otherwise.

What is being tested?

The trial is testing a therapy where white blood cells from the patient's tumor are grown in large numbers and reinfused into them. The study aims to see if these Tumor Infiltrating Lymphocytes (TIL) can shrink tumors effectively and safely.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the cell transfer process, fatigue due to high cell growth activity, and complications from chemotherapy drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 72 years old.

Select...

My cancer is metastatic and falls into one of the specified categories.

Select...

I have up to 3 small, symptom-free brain tumors.

Select...

My cancer did not respond to standard treatments.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any active infections, bleeding disorders, or serious illnesses.

Select...

My lung function (FEV1) is 50% or less.

Select...

I do not have any current infections.

Select...

I have had heart surgery or symptoms of reduced blood flow to my heart.

Select...

My liver function score is moderate to severe due to my liver cancer.

Select...

I have an autoimmune disease affecting a major organ.

Select...

I am currently pregnant or breastfeeding.

Select...

My advanced cancer is causing blockage, risk of hole formation, or bleeding that requires blood transfusions.

Select...

I have had severe side effects from anti-PD-1/PD-L1 cancer therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Secondary study objectives

Frequency and severity of treatment-related adverse events

Safety and efficacy of pembrolizumab in combination with TIL therapy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: 4/Unselected TIL + Pembro at PODExperimental Treatment5 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin + pembrolizumab within 4 weeks of progressive disease for up to 8 doses every 3 weeks

Group II: 3/Unselected TIL + Pembro Prior to CellsExperimental Treatment5 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin + pembrolizumab prior to cell administration and 3 additional doses every 3 weeks following cell infusion

Group III: 2/Unselected TIL (CLOSED)Experimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin (CLOSED)

Group IV: 1/CD8+ Enriched TIL (CLOSED)Experimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young CD8+ enriched TIL + high-dose aldesleukin (CLOSED)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Young TIL

2012

Completed Phase 2

~70