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CAR T-cell Therapy

Armored CAR T-Cell Therapy for Pediatric Solid Cancers

Phase 1

Recruiting

Led By David Steffin, MD

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/µl, platelet count > 25,000/µl (can be transfused), Hgb ≥ 7.0 g/dl (can be transfused), Pulse oximetry >90% on room air, Refractory or relapsed disease after treatment with up-front therapy and at least one salvage treatment cycle, 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

Child-Pugh-Turcotte score < 7 (for patients with hepatocellular carcinoma only)

Must not have

Uncontrolled infection

History of organ transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people with cancer that has returned or has not gone away after standard treatment, and/or for people who cannot receive standard treatment.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with certain solid tumors that haven't responded to standard treatments or when such treatments aren't an option. Participants need good organ function, no uncontrolled infections, not be on high-dose steroids, and can't be pregnant or have HIV. They must also agree to effective birth control post-treatment.

What is being tested?

The study tests CARE T cells (genetically modified T cells) in patients with GPC3-positive tumors. These T cells are engineered to target cancer more effectively by recognizing a specific protein on tumor cells. The trial aims to determine the highest safe dose of these cells, their lifespan in the body, side effects, and effectiveness against the cancer.

What are the potential side effects?

Potential side effects include immune reactions where the body attacks its own tissues (autoimmunity), symptoms related to infusion like fever or chills, fatigue, blood count changes increasing infection risk, and possibly severe complications requiring emergency treatment.

Eligibility Criteria

Inclusion Criteria

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

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My liver is functioning well enough for treatment.

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I can care for myself but may need occasional help.

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My tumor is GPC3-positive and has relapsed or is not responding to treatment.

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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.

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I can care for myself but may need occasional help.

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I am between 1 and 21 years old.

Exclusion Criteria

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

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I do not have any infections that aren't responding to treatment.

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I have had an organ transplant.

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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

Manufacturing feasibility of 21.15.GBBz T cells

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: CARE T cells + Fludarabine and CytoxanExperimental Treatment3 Interventions

GPC3-CAR and the IL15 plus IL21 (CARE 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