B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)
Sponsor: St. Jude Children's Research Hospital
A observational or N/A phase clinical study on Adrenocortical Cancer and Carcinoma, this trial is actively recruiting participants. The trial is conducted by St. Jude Children's Research Hospital and has accumulated 12 data snapshots since 2022. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)Treatment will include a single infusion of B7-H3-CAR T cells after lymphodepleting chemotherapy, with dosing based on the number of CAR+ T cells and patient weight. The study will evaluate the safety and maximum tolerated dose (MTD) of B7-H3-CAR T cells, using a standard 3+3 study design and a 6-week evaluation period. The total study duration will be 1 year, at which point patients will enroll on our existing institutional long-term follow-up protocol.
Treatment will include a single infusion of B7-H3-CAR T cells after lymphodepleting chemotherapy, with dosing based on the number of CAR+ T cells and patient weight. The study will evaluate the safety and maximum tolerated dose (MTD) of B7-H3-CAR T cells, using a standard 3+3 study design and a 6-week evaluation period. The total study duration will be 1 year, at which point patients will enroll on our existing institutional long-term follow-up protocol.
Status Flow
Change History
12 versions recorded-
Apr 16, 2026 — Present [daily]
Recruiting
Phase: PHASE1 → None
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Nov 2025 — Apr 2026 [monthly]
Recruiting PHASE1
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May 2025 — Nov 2025 [monthly]
Recruiting PHASE1
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Sep 2024 — May 2025 [monthly]
Recruiting PHASE1
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE1
▶ Show 7 earlier versions
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Sep 2023 — Jul 2024 [monthly]
Recruiting PHASE1
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Apr 2023 — Sep 2023 [monthly]
Recruiting PHASE1
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Feb 2023 — Apr 2023 [monthly]
Recruiting PHASE1
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Sep 2022 — Feb 2023 [monthly]
Recruiting PHASE1
Status: Not Yet Recruiting → Recruiting
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May 2022 — Sep 2022 [monthly]
Not Yet Recruiting PHASE1
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Oct 2021 — May 2022 [monthly]
Not Yet Recruiting PHASE1
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Jun 2021 — Oct 2021 [monthly]
Not Yet Recruiting PHASE1
First recorded
Eligibility Summary
3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells
Contact Information
- St. Jude Children's Research Hospital
For direct contact, visit the study record on ClinicalTrials.gov .