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CAR T-cell Therapy

Genetically Modified T-Cells + Aldesleukin for Melanoma

Phase 1

Waitlist Available

Led By Rodabe N Amaria

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

Patients must have metastatic melanoma or stage III in-transit, subcutaneous, or regional nodal disease

Patients must have a lesion amenable to resection or the collection of up to 5 needle core samples for the generation of TIL

Must not have

Patients with prior bone marrow or stem cell transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Approved for 20 Other Conditions

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing genetically modified T-cells followed by aldesleukin to treat melanoma. T-cells are a type of white blood cell that help the body fight infections. Genes that may help the T-cells recognize melanoma cells are placed into the T-cells in the laboratory. Adding these genes to the T cells may help them kill more tumor cells when they are put back in the body. Aldesleukin may enhance this effect by stimulating white blood cells to kill more melanoma cells.

Who is the study for?

This trial is for adults with stage III-IV melanoma who have adequate lung function, no severe psychiatric diseases, and are not pregnant or nursing. Participants must not have had recent cancer treatments, organ transplants, significant medical illnesses, or be on chronic steroids. They need measurable melanoma lesions suitable for T-cell generation and agree to use birth control.

What is being tested?

The trial tests genetically modified T-cells designed to target melanoma followed by aldesleukin (a substance that can boost the immune system). It aims to find the best dose and observe side effects. The process involves modifying patients' own T-cells in a lab before reintroducing them into their bodies.

What are the potential side effects?

Potential side effects may include reactions related to the immune system's enhancement such as flu-like symptoms from aldesleukin (fever, chills), fatigue, risk of infection due to white blood cell changes, and possible tissue damage at injection sites.

Eligibility Criteria

Inclusion Criteria

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

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My melanoma has spread or is in stage III.

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I have a tumor that can be surgically removed or sampled.

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I have a melanoma spot that can be biopsied and is at least 1 cm big.

Exclusion Criteria

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

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I have had a bone marrow or stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

(Cohort A) Generation of TGF alpha (TGFa)-DNRII and NGFR transduced tumor infiltrating lymphocytes (TILs)

(Cohort B) The primary endpoint of growing enough TIL for patient treatment and sample size is 15 patients.

Secondary study objectives

(Cohort A) Number of DNRII transduced cells

(Cohort A) Number of NGFR transduced cells at infusion

(Cohort A) Number of NGFR transduced cells based on tumor biopsy

+1 more

Awards & Highlights

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

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

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (chemotherapy, autologous T-cell immunotherapy)Experimental Treatment6 Interventions

Patients receive cyclophosphamide IV over 2 hours on days -7 and -6, fludarabine phosphate IV daily over 15-30 minutes on days -5 to -1, and TGFb DNRII-transduced autologous TIL and NGFR-transduced autologous T lymphocytes IV over up to 4 hours on day 0. Patients then receive high-dose aldesleukin IV over 15 minutes every 8-16 hours on days 1-5 (up to 15 doses) and 22-26 (up to 15 doses).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aldesleukin

FDA approved

Cyclophosphamide

FDA approved

Fludarabine

FDA approved

NGFR-transduced Autologous T Lymphocytes

2015