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NCT04385173
Pilot Study of B7-H3 CAR-T in Treating Patients With Recurrent and Refractory Glioblastoma
Phase 1 trial testing B7-H3 CAR-T in Recurrent Glioblastoma in 12 participants. Status unknown.
1 March 2024
Quick facts
| Lead sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 December 2022 |
| Primary completion | 1 March 2024 |
| Estimated completion | 1 May 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- B7-H3 CAR-T — full drug profile →
- Temozolomide (temozolomide) — full drug profile →
Conditions studied
- Recurrent Glioblastoma — all drugs for Recurrent Glioblastoma →
- Refractory Glioblastoma — all drugs for Refractory Glioblastoma →
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Who can join
Adults 18 to 75, any sex, with Recurrent Glioblastoma or Refractory Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a pilot phase I study to evaluate the safety and efficacy on B7-H3 CAR-T in between Temozolomide cycles in treating patients with glioblastoma that has come back or does not respond to the standard treatment. The antigen B7-H3 is highly expressed in glioblastoma of a subset of patients. B7-H3 CAR-T, made from isolated patient peripheral blood mononuclear cells, can specifically attack patient glioblastoma cells that expressing B7-H3.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Glioblastoma multiforme (GBM): An overview of current therapies and mechanisms of resistance.
Wu W, Klockow JL, Zhang M, Lafortune F, et al · · 2021 · cited 532× · PMID 34302977 · DOI 10.1016/j.phrs.2021.105780 -
B7-H3: An Attractive Target for Antibody-based Immunotherapy.
Kontos F, Michelakos T, Kurokawa T, Sadagopan A, et al · · 2021 · cited 311× · PMID 33051306 · DOI 10.1158/1078-0432.ccr-20-2584 -
CAR T Cell Therapy for Solid Tumors: Bright Future or Dark Reality?
Wagner J, Wickman E, DeRenzo C, Gottschalk S. · · 2020 · cited 284× · PMID 32979309 · DOI 10.1016/j.ymthe.2020.09.015 -
Understanding the immunosuppressive microenvironment of glioma: mechanistic insights and clinical perspectives.
Lin H, Liu C, Hu A, Zhang D, et al · · 2024 · cited 232× · PMID 38720342 · DOI 10.1186/s13045-024-01544-7 -
B7-H3/CD276: An Emerging Cancer Immunotherapy.
Zhou WT, Jin WL. · · 2021 · cited 204× · PMID 34349762 · DOI 10.3389/fimmu.2021.701006 -
Immune checkpoint modulators in cancer immunotherapy: recent advances and emerging concepts.
Wang Y, Zhang H, Liu C, Wang Z, et al · · 2022 · cited 179× · PMID 35978433 · DOI 10.1186/s13045-022-01325-0 -
Immune checkpoint of B7-H3 in cancer: from immunology to clinical immunotherapy.
Zhao B, Li H, Xia Y, Wang Y, et al · · 2022 · cited 145× · PMID 36284349 · DOI 10.1186/s13045-022-01364-7 -
CAR T Cell-Based Immunotherapy for the Treatment of Glioblastoma.
Maggs L, Cattaneo G, Dal AE, Moghaddam AS, et al · · 2021 · cited 113× · PMID 34113233 · DOI 10.3389/fnins.2021.662064
Verify or expand the search:
- PubMed search for NCT04385173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of B7-H3 CAR-T
Trials testing the same drug.
- NCT04077866 — B7-H3 CAR-T for Recurrent or Refractory Glioblastoma · Phase 1, PHASE2 · unknown
Other recruiting trials for Recurrent Glioblastoma
Currently open trials in the same condition.
- NCT07480941 — Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grade Glioma · Phase 1 · recruiting
- NCT07209241 — Different Approaches for CART-EGFR-IL13Ra2 Dosing in Recurrent GBM · Phase 1 · recruiting
- NCT06910306 — Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Glioblastoma · NA · recruiting
- NCT07193628 — B7H3/IL13Ra2 Bispecific Armored Chimeric Antigen Receptor T-Cell Therapy Study for Recurrent/Refractory Glioblastoma · Phase 1 · recruiting
- NCT07076472 — Sonodynamic Therapy With SONALA-001 or 5-ALA HCL and Magnetic Resonance Guided Focused Ultrasound for the Treatment of P · EARLY_PHASE1 · recruiting
Other Second Affiliated Hospital, School of Medicine, Zhejiang University trials
Trials by the same sponsor.
- NCT07445152 — Research on Construction and Verification of Multimodal Medical Imaging Large Model · not yet recruiting
- NCT06775665 — A Real-World Study on Hypertrophic Cardiomyopathy in Chinese Population · not yet recruiting
- NCT07533422 — Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing · NA · not yet recruiting
- NCT07487285 — A Non-inferiority Study of Laser Combined With Ultrasonic Debridement Therapy (LCUDT) Versus Manual Combined With Ultras · NA · not yet recruiting
- NCT07505186 — Camrelizumab, Chemotherapy and Ivarmacitinib in Patients With Resectable Esophageal Squamous Cell Carcinoma · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04385173 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Second Affiliated Hospital, School of Medicine, Zhejiang University
- Last refreshed: 28 December 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04385173.
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