GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT) (NCT07513194) | Clinical Trial Compass
Not Yet RecruitingPhase 1
GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT)
United States21 participantsStarted 2026-09-01
Plain-language summary
This study is being conducted in patients with GPC3-positive brain tumors that have recurred or have not responded to standard therapy. Atypical teratoid rhabdoid tumors (ATRT) are aggressive tumors with poor outcomes and limited treatment options, particularly in young children. There is a need for new therapies that can improve outcomes while minimizing toxicity.
This study evaluates a new experimental treatment using genetically engineered T cells (RADIANT-T cells) that target glypican-3 (GPC3), a protein expressed on tumor cells. These T cells are modified to express a chimeric antigen receptor (CAR) targeting GPC3, along with IL-15 and IL-21 to enhance their persistence and activity. The cells also include an inducible safety mechanism (iCasp9) that allows them to be eliminated if necessary.
The purpose of this study is to determine the highest safe dose of RADIANT-T cells, evaluate their safety and side effects, assess how long they persist in the body, and determine whether they show anti-tumor activity in patients with GPC3-positive brain tumors.
Who can participate
Age range1 Year – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Procurement Inclusion Criteria:
* 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)
Procurement Exclusion Criteria:
* 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
Treatment Inclusion Criteria:
* 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 …
What they're measuring
1
Number of Participants with Dose-Limiting Toxicity
Timeframe: 4 weeks after CAR T-cell administration