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CAR T-cell Therapy

Armored CAR T-Cell Therapy for Pediatric Solid Cancers

Phase 1
Waitlist Available
Led By Andras Heczey, 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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My liver cancer is at an early to intermediate stage.

Timeline

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

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

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
998 Previous Clinical Trials
6,001,888 Total Patients Enrolled
3 Trials studying Liver Cancer
5,534 Patients Enrolled for Liver Cancer
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,793 Total Patients Enrolled
2 Trials studying Liver Cancer
34 Patients Enrolled for Liver Cancer
Andras Heczey, MDPrincipal InvestigatorBaylor College of Medicine
4 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Liver Cancer
24 Patients Enrolled for Liver Cancer

Media Library

CARE T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04715191 — Phase 1
Liver Cancer Research Study Groups: CARE T cells + Fludarabine and Cytoxan
Liver Cancer Clinical Trial 2023: CARE T cells Highlights & Side Effects. Trial Name: NCT04715191 — Phase 1
CARE T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04715191 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned any CARE T cell treatments?

"CARE T cells, which are currently undergoing testing in a phase 1 clinical trial and have only limited evidence of safety and efficacy, were given an initial score of 1."

Answered by AI

What is the current enrollment size for this medical experiment?

"As of now, this clinical trial is not enrolling participants. It was originally posted on July 3rd 2023 and last revised on December 1st 2021. For those interested in participating in medical studies, there are currently 2538 trials for Wilms Tumor recruiting patients, as well as 889 studies relating to CAR-T cells which require volunteers."

Answered by AI

What credentials must a participant possess to take part in this research?

"This trial is seeking 24 children between 1 year and 21 years of age who are currently diagnosed with Wilms tumour. Additionally, participants need to meet the following criteria: a Lansky/Karnofsky performance score of 60% or higher; completion & signing of an informed consent form given by the patient/guardian; eligibility for procurement; relapse or refractory GPC3-positive* solid tumors (as determined by immunohistochemistry); life expectancy longer than 16 weeks; Barcelona Clinic Liver cancer Stage A, B or C (for patients with hepatocellular carcinoma only); Child-Pugh-Turc"

Answered by AI

What medical conditions can be addressed with CARE T cell treatments?

"Several maladies, including multiple sclerosis, mixed-cell type lymphoma and acute myelocytic leukemia can be remedied with CARE T cells."

Answered by AI

Are recruitment efforts still underway for this research project?

"This clinical trial is not currently accepting new enrollees, as per the information recorded on clinicaltrials.gov. While this study was initially posted in July of 2023 and most recently updated in December 2021, there are 3,427 other trials actively searching for participants at present."

Answered by AI

Has there been any prior experimentation involving CARE T cells in a clinical setting?

"Presently, there are 889 ongoing medical studies assessing CARE T cells with 161 trials at Phase 3. Philadelphia holds numerous of the examinations for CARE T cells, but 28443 locations across the nation have active experiments involving this cellular therapy."

Answered by AI

Does this investigation include participants aged fifty or above?

"This clinical trial has a minimum participation age of 1 year old and a maximum age limit of 21 years."

Answered by AI
~16 spots leftby Aug 2026