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CAR T-cell Therapy

CAR T-Cell Therapy for Liver Cancer (GAP Trial)

Phase 1

Waitlist Available

Led By Andras A Heczey, M.D.

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

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

Must have

Adequate organ function: Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min, serum AST< 5 times ULN, total bilirubin < 3 times ULN for age, INR ≤1.7 (for patients with hepatocellular carcinoma only), absolute neutrophil count > 500/microliter, platelet count > 25,000/microliter (can be transfused), Hgb ≥7.0 g/dl (can be transfused), pulse oximetry >90% on room air, Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study, Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion, Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

Lansky or Karnofsky score ≥ 60%

Must not have

History of organ transplantation

Severe previous toxicity from cyclophosphamide or fludarabine

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to fight cancer by genetically engineering a patient's own T cells to attack their tumor.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with GPC3-positive solid liver tumors that have either returned after treatment, haven't responded to standard treatments, or can't be treated conventionally. Participants need a reasonable life expectancy and good performance status, but those with organ transplants, HIV, active infections (except certain hepatitis), severe reactions to Cytoxan or Fludara, or allergies to murine proteins are excluded.

What is being tested?

The GAP clinical trial is testing a new therapy using GAP T cells—immune cells modified with a chimeric antigen receptor targeting glypican-3 on cancer cells. The study aims to determine the highest safe dose of these engineered T cells, their lifespan in the body, side effects they may cause, and their effectiveness against liver tumors.

What are the potential side effects?

Potential side effects from GAP T cell therapy could include immune system reactions like inflammation in various organs due to targeted attack by the modified T cells. Side effects related to Cytoxan and Fludara might involve nausea, hair loss, mouth sores or increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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I can do most activities but may need help.

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I am mostly able to carry out daily activities.

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My liver cancer has returned or did not respond to treatment and tests positive for GPC3.

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I am between 1 and 21 years old.

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My liver cancer is at an early to intermediate stage.

Exclusion Criteria

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

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I have had an organ transplant.

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I had severe side effects from cyclophosphamide or fludarabine.

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I do not have any infections that are not responding to treatment.

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I do not have any active infections, except possibly Hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 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

Number of Patients with Dose Limiting Toxicity

Secondary study objectives

Median T cell persistence

Percent of Patients with best response as either complete remission or partial remission

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: GAP T cells + Fludarabine and CytoxanExperimental Treatment3 Interventions

GPC3-Car (GAP T cells) along with lymphodepleting chemotherapy (Cytoxan and Fludarabine) will be administered to patients with GPC3-positive solid tumors.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cytoxan

2007

Completed Phase 3

~1460

Fludara

2017

Completed Phase 2

~30