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RADIANT Study: GPC3 CAR T Cells for Recurrent Brain Tumors

This study is testing an experimental treatment called 21.15.GPC3-CAR T Cells for children and young adults (ages 1 to 21) with specific types of brain tumors (Atypical Teratoid Rhabdoid Tumor and Central Nervous System Rhabdoid Tumor) that have come back or haven't responded to standard treatments. These tumors must have a protein called GPC3. The treatment involves taking your own immune cells (T cells), modifying them in the lab to recognize and fight the GPC3 protein on tumor cells, and then giving them back to you. The main goal of this study is to see how safe this treatment is and to find the highest dose that can be given without causing severe side effects. This is an immunotherapy approach, meaning it uses your body's own immune system to fight cancer.

Study design
This is a Phase 1 dose-escalation study, meaning groups of patients will receive increasing doses of the treatment to find the safest and most effective amount. About 21 patients are planned to participate.
What's involved
Your T cells will be collected, and you will receive a single dose of the modified T cells during a planned surgery. An Ommaya reservoir (a small device placed under the scalp) will be used for monitoring. You will have clinical evaluations, including physical exams, lab tests, and imaging, before treatment.
Compensation
Not stated in the trial record.
Follow-up
The study will measure dose-limiting toxicities (severe side effects) for 4 weeks after the CAR T-cell administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07513194

GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT)

Not Yet Recruiting
PHASE1Ages 1–21InterventionalTreatment
Baylor College of Medicine
~21 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:21.15.GPC3-CAR T Cells

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Dose-Limiting Toxicity
Measured over 4 weeks after CAR T-cell administration

Conditions

Atypical Teratoid Rhabdoid Tumor
Central Nervous System Rhabdoid Tumor

Explore related trials

Atypical Teratoid Rhabdoid TumorAtypical Teratoid/Rhabdoid TumorGlypican-3

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • David Steffin, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine
  • Jasia Mahdi, MD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

David Steffin, MD
[email protected]
(832) 824-4233
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

1\) Diagnosis of GPC3-positive recurrent ATRT.
2\) Age ≥ 6 months
3\) Karnofsky/Lansky score ≥ 60%
4\) Informed consent explained to, understood by, and signed by patient/guardian; copy provided
5\) GPC3 expression by immunohistochemistry with extent score ≥ Grade 2 (\>25% positive tumor cells) and intensity score ≥ 2 (scale 0-4)
1\) Age ≥ 6 months
2\) Diagnosis of treatment refractory or unresectable ATRT after standard of care therapy
3\) Lansky/Karnofsky score ≥ 60%
4\) Stable neurologic exam for 7 days prior to enrollment
5\) Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg/kg dexamethasone or equivalent per day)
6\) Not receiving any concurrent anti-cancer therapy.
7\) At least 6 weeks following craniospinal radiation therapy.
8\) At least 14 days wash-out needed following small volume radiotherapy (i.e., Stereotactic Radiosurgery (SRS)).
9\) At least 21 days or 5 half-lives (whichever is shorter) must have elapsed since any prior systemic therapy
10\) Received any other forms of immunotherapy ≤ 42 days before administration of investigational agent
11\) At least 28 days following bevacizumab
12\) Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min
13\) Total bilirubin \< 3 times ULN for age
14\) INR ≤ 1.7
15\) Absolute neutrophil count \> 500/μl
16\) Platelet count \> 100,000/μl (can be transfused but must be achieved prior to enrollment)
17\) Hgb ≥ 7.0 g/dl (can be transfused)
18\) Pulse oximetry \> 90% on room air
19\) Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
20\) Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion.
21\) Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent

Exclusion

1\) No history of organ transplantation
2\) No known HIV positivity
3\) No active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
4\) No other risk factors in which administration of the investigational agent is deemed not in the patient's best interest, in the opinion of the investigator
1\) Pregnancy or lactation (for women at child-bearing age, birth control is required)
2\) Uncontrolled infection
3\) Known HIV positivity
4\) Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections)
5\) History of organ transplantation

What this trial measures

  • Number of Participants with Dose-Limiting Toxicity4 weeks after CAR T-cell administration

    DLT will be defined as any of the following that may be considered possibly, probably, or definitely related to the 21.15.GPC3-CAR T cells: Any Grade 5 event, Non-hematologic dose-limiting toxicity (any Grade 4 non-hematologic toxicity that fails to return to Grade 2 within 72 hours), Grade 4 allergic reaction to CAR T cell administration, Grade 4 reactions due to CRS and neurotoxicity (rarely seen with the use of CAR-based immunotherapy), Grade 3 cytokine release syndrome (CRS) infusion reactions and neurologic toxicity that fail to return to Grade 1 within 72 hours, Grade 4 CRS and neurologic toxicities