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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])
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, 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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Your kidneys, liver, and blood need to work well. You must have a certain level of blood cells, oxygen, and be recovered from previous treatments. If you are sexually active, you need to use effective birth control for 3 months after the treatment.
Select...
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.

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: 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?

Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,913 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 Investigator - Baylor College of Medicine
Baylor College of Medicine
4 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Liver Cancer
24 Patients Enrolled for Liver Cancer

Media Library

AGAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04377932 — Phase 1
Liver Cancer Research Study Groups: AGAR T cells
Liver Cancer 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

Frequently Asked Questions

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

Is the age range of participants in this trial extending beyond 40 years old?

"The permitted age range for patient recruitment in this medical trial is between 1 and 21 years of age."

Answered by AI

What maladies has AGAR T cells been established to mitigate?

"AGAR T cells are primarily used to combat multiple sclerosis, yet it may also be effective at treating conditions such as lymphoma, leukemia, myelocytic diseases, acute illnesses and retinoblastoma."

Answered by AI

Has AGAR T cell technology been tested in another trial prior to this one?

"Presently, 889 clinical trials are being conducted for AGAR T cells with 161 of them at Phase 3. 28443 sites across the world have studies underway regarding this treatment, though most locations are in Philadelphia, Pennsylvania."

Answered by AI

For what population is enrollment being accepted for this research study?

"Qualified applicants for this clinical trial must have rhabdomyosarcoma and be between one year of age up to twenty-one. In total, 24 patients are sought after by the research team."

Answered by AI

How many volunteers have been included in this experiment?

"Affirmative, the clinicaltrials.gov data suggest that this study is currently open for recruitment; it was first posted on December 8th 2021 and recently revised on April 18th 2022. The research seeks 24 participants from a single medical facility."

Answered by AI

Are applications to participate in this experiment currently being accepted?

"Indeed, research posted on clinicaltrials.gov attests that this investigation is currently seeking participants. It was initially published on December 8th 2021 and has been amended as of April 18th 2022. The trial needs to enrol 24 patients from a single medical centre."

Answered by AI

Has the FDA granted authorization to use AGAR T cells therapeutically?

"Our team has calculated the safety of AGAR T cells to be a 1, as this is an early phase trial with only limited information about its efficacy and safety."

Answered by AI
~6 spots leftby Feb 2025