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CAR T-cell Therapy

AGAR T Cell Therapy for Pediatric Solid Cancers

Phase 1
Recruiting
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
Diagnosis of GPC3-positive solid tumors (as determined by immunohistochemistry with an extent score of >=Grade 2 [>25% positive tumor cells] and an intensity score of >= 2 [scale 0-4])
Barcelona Clinic Liver Cancer Stage A, B or C (for patients with hepatocellular carcinoma only)
Must not have
History of organ transplantation
Uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is for patients with solid tumors that have a protein called GPC3 on the surface of the tumor cells.

Who is the study for?
This trial is for children and young adults aged 1 to 21 with certain solid tumors like liver cancer, rhabdoid tumor, or Wilms tumor that have not responded to standard treatments. Participants need a minimum level of physical functioning (Lansky/Karnofsky score ≥60%), adequate organ function, and must not be pregnant or breastfeeding. They should also have no history of severe allergic reactions to mouse proteins.
What is being tested?
The trial tests AGAR T cells, which are genetically engineered immune cells designed to target GPC3-positive solid tumors in pediatric patients. These T cells include a chimeric antigen receptor (CAR) targeting the GPC3 protein on cancer cells and IL15 for enhanced performance. The study aims to determine the highest safe dose, how long these cells last in the body, their side effects, and effectiveness against the tumors.
What are the potential side effects?
Potential side effects may include an immune response where the body attacks its own tissues (autoimmunity), symptoms similar to flu such as fever and fatigue due to immune activation (cytokine release syndrome), neurological issues like confusion or seizures, blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is GPC3-positive with more than 25% of cells affected and a high intensity score.
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My liver cancer is at an early to intermediate stage.
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I am between 1 and 21 years old.
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I can care for myself but may need occasional help.

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 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 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: AGAR T cellsExperimental Treatment1 Intervention
GPC3-CAR and the IL15 (AGAR T cells) will be administered to patients with GPC3-positive solid tumors.

Find a Location

Who is running the clinical trial?

Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
112 Previous Clinical Trials
2,830 Total Patients Enrolled
3 Trials studying Wilms Tumor
72 Patients Enrolled for Wilms Tumor
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,138 Total Patients Enrolled
3 Trials studying Wilms Tumor
72 Patients Enrolled for Wilms Tumor
Andras Heczey, MDPrincipal Investigator - Baylor College of Medicine
Baylor College of Medicine
4 Previous Clinical Trials
99 Total Patients Enrolled
2 Trials studying Wilms Tumor
45 Patients Enrolled for Wilms Tumor
David Steffin, MDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
45 Total Patients Enrolled
2 Trials studying Wilms Tumor
45 Patients Enrolled for Wilms Tumor

Media Library

AGAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04377932 — Phase 1
Wilms Tumor Research Study Groups: AGAR T cells
Wilms Tumor Clinical Trial 2023: AGAR T cells Highlights & Side Effects. Trial Name: NCT04377932 — Phase 1
AGAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04377932 — Phase 1
~1 spots leftby Feb 2025
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