Sponsor study identifier
interventional
21
1 country
1
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2044
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 31, 2044
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2026
Actual (reported)April 7, 2026
Actual (reported)September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 31, 2044
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Number of Participants with Dose-Limiting Toxicity
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
4 weeks after CAR T-cell administration
Maximum Tolerated Dose (MTD) of intratumoral and/or ICV injection of 21.15.GPC3-CAR T cells in treating patients with GPC3-positive recurrent or incompletely resected ATRT.
28 days
Participants will receive autologous 21.15.GPC3-CAR T cells administered intratumorally into the tumor resection cavity and/or intracerebroventricularly via an Ommaya reservoir. CAR T cells are genetically engineered using retroviral vectors encoding a GPC3-specific chimeric antigen receptor and cytokines IL-15 and IL-21. The following dose levels of CAR T cells will be evaluated: * DL0: 1 × 10⁷ CAR T cells * DL1: 3 × 10⁷ CAR T cells * DL2: 5 × 10⁷ CAR T cells * DL3: 1 × 10⁸ CAR T cells If dose de-escalation from DL1 is required, patients will be treated at DL0. Further de-escalation may use half-log reductions if needed. Dose escalation will occur only after safety evaluation of prior cohorts.
Autologous T cells genetically engineered using retroviral vectors encoding a GPC3-specific CAR and IL-15 and IL-21 cytokines. The product also includes an inducible caspase-9 safety switch allowing pharmacologic elimination of the CAR T cells in the event of severe toxicity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Texas Children's Hospital
Houston, Texas, 77030, United States
David Steffin, MD
Baylor College of Medicine
Jasia Mahdi, MD
Baylor College of Medicine
First Submitted
April 1, 2026
First Posted
April 7, 2026
Study Start
September 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 31, 2029
Response Rate
4-6 weeks after CAR T-cell administration
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 31, 2044
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 7, 2026
Record last verified: 2026-04
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Source: ClinicalTrials.gov.
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