B7-H3 CAR-T

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Also known as:

B7-H3CART B7-H3-CAR T Cells TX103 4SCAR-276 +1 more

Cancer types include:

kidney cancer melanoma ovarian cancer sarcoma

TrialFetch AI Analysis

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Overview

B7-H3 CAR-T refers to investigational, genetically engineered T-cell therapies directed at B7-H3 (CD276), a protein found on many tumors. It is not a single standardized product: published studies include the pediatric BrainChild-03 therapy and TX103 for recurrent glioblastoma, while 4SCAR-276 is a separately developed B7-H3–targeted CAR-T product. Human results are available, but they come mainly from small, early-phase trials. (pubmed.ncbi.nlm.nih.gov)

Mechanism of action

A chimeric antigen receptor (CAR) equips T cells to recognize B7-H3 on tumor cells and attack them. In the reported brain-tumor trials, cells were delivered directly into the brain’s ventricular fluid or another intracranial site, rather than solely through a vein. (pubmed.ncbi.nlm.nih.gov)

Efficacy

Pediatric diffuse intrinsic pontine glioma (BrainChild-03): Among 21 treated patients, median survival was 10.7 months from first infusion and 19.8 months from diagnosis. This single-arm phase 1 study cannot establish whether treatment extended survival. (pubmed.ncbi.nlm.nih.gov)
Other pediatric CNS tumors (BrainChild-03): Two of 26 treated patients had a partial response; median survival from first infusion was 11.5 months across a varied group of tumor types. (academic.oup.com)
Recurrent glioblastoma (TX103): Eight of 14 patients with measurable disease achieved stable disease or better, including one complete response. Median survival from first infusion was 19.1 months in the 15-patient phase 1 trial. (pubmed.ncbi.nlm.nih.gov)
Pediatric solid tumors: A preliminary 16-patient study reported eight cases of stable disease, seven of progression, and one not evaluable at the initial imaging assessment; no tumor responses were reported. (aacrjournals.org)

Safety

In BrainChild-03’s 21-patient pontine-glioma group, common adverse events included headache, fatigue and fever; one dose-limiting intratumoral hemorrhage occurred. No dose-limiting toxicities were observed among the 26 treated patients in its other CNS-tumor groups. In the TX103 trial, there were no dose-limiting toxicities, but three serious grade 3 treatment-related events occurred: elevated intracranial pressure, epilepsy and depressed consciousness. These small studies cannot define longer-term safety or comparative benefit. (pubmed.ncbi.nlm.nih.gov)

Active trials using B7-H3 CAR-T

Found 4 active trials using this drug:

Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcomas

Sponsor: St. Jude Children's Research Hospital (other) Phase: 1 Start date: Oct. 30, 2025

TrialFetch AI summary: Patients aged 21 years or younger with relapsed or refractory B7-H3–positive sarcoma and at least one lesion suitable for radiation receive hypofractionated radiation and fludarabine/cyclophosphamide lymphodepletion, followed by autologous B7-H3 (CD276)–directed CAR T cells engineered to attack tumor cells.

ClinicalTrials.gov ID: NCT07222735

Phase I Clinical Trial of Autologous B7-H3 Chimeric Receptor (CAR) T Cells in Adults With Recurrent, Platinum Resistant Ovarian Tumors

Sponsor: Stanford University (other) Phase: 1 Start date: Nov. 11, 2024

TrialFetch AI summary: Adults with measurable recurrent ovarian carcinoma that is platinum-refractory or recurred within 6 months of platinum therapy after at least one platinum-based regimen receive autologous CAR T cells targeting B7-H3 (CD276). Cells are infused intraperitoneally for eligible peritoneum-confined disease or intravenously for disease outside the peritoneum or when intraperitoneal delivery is unsuitable.

ClinicalTrials.gov ID: NCT06646627

Phase I Clinical Trial of Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Children and Young Adults With Relapsed or Refractory Solid Tumor Expressing B7-H3 Target

Sponsor: Crystal Mackall, MD (other) Phase: 1 Start date: July 11, 2024

TrialFetch AI summary: Children and young adults aged 2–30 years with incurable relapsed or refractory solid tumors may receive lymphodepletion with fludarabine and cyclophosphamide followed by a single intravenous infusion of autologous CAR T cells engineered to target B7-H3 (CD276). Tumor B7-H3 positivity is not required, but tissue must be available for testing.

ClinicalTrials.gov ID: NCT06500819

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

Sponsor: St. Jude Children's Research Hospital (other) Phase: 1 Start date: July 6, 2022

TrialFetch AI summary: Patients aged 21 years or younger with measurable, B7-H3–positive solid tumors that have relapsed or are refractory after first-line therapy receive lymphodepleting fludarabine and cyclophosphamide followed by a single infusion of autologous CAR T cells engineered to target B7-H3 (CD276) on tumor cells.

ClinicalTrials.gov ID: NCT04897321