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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%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

GAP Trial 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.Check my eligibility

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.See study design

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.

GAP Trial 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.

GAP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients with Dose Limiting Toxicity

Secondary outcome measures

Median T cell persistence

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

GAP 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

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cookies for Kids' CancerOTHER

6 Previous Clinical Trials

348 Total Patients Enrolled

Curing Kids' Cancer FoundationOTHER

The V FoundationOTHER

6 Previous Clinical Trials

159 Total Patients Enrolled

Media Library

GAP T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02932956 — Phase 1

Liver Cancer Clinical Trial 2023: GAP T cells Highlights & Side Effects. Trial Name: NCT02932956 — Phase 1

GAP T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02932956 — Phase 1

Liver Cancer Research Study Groups: GAP T cells + Fludarabine and Cytoxan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities to join this clinical trial?

"The clinicaltrials.gov records indicate that this trial, which was initially posted on December 17th 2018 and last updated in April 18th 2022, is not currently enrolling participants. Despite this fact, 1140 other trials are actively seeking candidates for their studies."

Answered by AI

What other investigations have been conducted concerning the effects of GAP T cells?

"Currently, 889 studies are being conducted concerning GAP T cells, with 161 of those in their final phase. Most experiments associated to this therapy take place in Philadelphia, PA; however there are 28443 locations conducting research for the same purpose across the nation."

Answered by AI

What is the optimal demographic to recruit for this research?

"This trial is open to children, aged between one and 21 years old, with liver neoplasms. In addition to meeting this demographic criteria, the participants must have less than a 7 Child-Pugh-Turcotte score (for those with hepatocellular carcinoma only), meet Procurement Eligibility requirements, be diagnosed with relapsed or refractory GPC3 positive solid tumours (currently only enrolling patients who present in their livers); possess a Lansky or Karnofsky score of at least 60% ; live for more than 16 weeks; and provide informed consent that has been explained, understood"

Answered by AI

Does this trial encompass individuals below the age of thirty?

"To be considered for this trial, patients must fall between the ages of 1 to 21. The clinicaltrials.gov website lists 332 studies that involve participants under 18 years old and 906 trials with individuals over 65."

Answered by AI

How many participants have enrolled in this research?

"Unfortunately, this trial has not been accepting new candidates for some time; it was initially posted on December 17th 2018 and last updated April 18th 2022. If you are looking to join other medical studies, there are currently 251 trials open for liver neoplasms patients and another 889 clinical trials seeking GAP T cell participants."

Answered by AI

What conditions are GAP T cells commonly employed to address?

"GAP T cells are frequently used to manage multiple sclerosis but may also be administered for other ailments such as mixed-cell type lymphoma, acute leukemia, myelocytic cancer and retinoblastoma."

Answered by AI