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NCT05211557
Study of Fully Human B7H3 CAR-T in Treating Recurrent Malignant Ovarian Cancer
Phase 1, PHASE2 trial testing fhB7H3.CAR-Ts in Ovarian Cancer in 15 participants. Currently enrolling.
31 August 2023
Quick facts
| Lead sponsor | The Affiliated Hospital of Xuzhou Medical University |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 16 November 2021 |
| Primary completion | 31 August 2023 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- fhB7H3.CAR-Ts — full drug profile →
Conditions studied
- Ovarian Cancer — all drugs for Ovarian Cancer →
Sponsor
The Affiliated Hospital of Xuzhou Medical University
Who can join
Adults 18 to 70, female only, with Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is single center, open-label phase I, non-randomized study which will enroll patients with recurrent advanced ovarian cancer to evaluate the safety, feasibility, and efficacy of fully human B7H3 CAR-T cells (fhB7H3.CAR-Ts) via using a '3+3+3' dose escalation design. In the dose expansion cohort, six patients will be enrolled to further assess their efficacy with the optimal dosage.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
T cells in health and disease.
Sun L, Su Y, Jiao A, Wang X, et al · · 2023 · cited 717× · PMID 37332039 · DOI 10.1038/s41392-023-01471-y -
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 -
Current advances and challenges in CAR T-Cell therapy for solid tumors: tumor-associated antigens and the tumor microenvironment.
Yan T, Zhu L, Chen J. · · 2023 · cited 132× · PMID 36707873 · DOI 10.1186/s40164-023-00373-7 -
Harnessing the potential of CAR-T cell therapy: progress, challenges, and future directions in hematological and solid tumor treatments.
Dagar G, Gupta A, Masoodi T, Nisar S, et al · · 2023 · cited 130× · PMID 37420216 · DOI 10.1186/s12967-023-04292-3 -
B7-H3 Inhibitors in Oncology Clinical Trials: A Review.
Feustel K, Martin J, Falchook GS. · · 2024 · cited 45× · PMID 38327753 · DOI 10.36401/jipo-23-18 -
T Cell Based Immunotherapy for Cancer: Approaches and Strategies.
Want MY, Bashir Z, Najar RA. · · 2023 · cited 44× · PMID 37112747 · DOI 10.3390/vaccines11040835 -
CAR-T Cell Therapy in Ovarian Cancer: Where Are We Now?
Cutri-French C, Nasioudis D, George E, Tanyi JL. · · 2024 · cited 23× · PMID 38667465 · DOI 10.3390/diagnostics14080819 -
Infusion and delivery strategies to maximize the efficacy of CAR-T cell immunotherapy for cancers.
Gu X, Zhang Y, Zhou W, Wang F, et al · · 2024 · cited 21× · PMID 39061100 · DOI 10.1186/s40164-024-00542-2
Verify or expand the search:
- PubMed search for NCT05211557
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of fhB7H3.CAR-Ts
Trials testing the same drug.
- NCT05323201 — Study Of B7H3 CAR-T Cells in Treating Advanced Liver Cancer · Phase 1, PHASE2 · recruiting
Other recruiting trials for Ovarian Cancer
Currently open trials in the same condition.
- NCT06412120 — Study Evaluating Safety, Tolerability, and Metabolism of Niraparib · Phase 4 · recruiting
- NCT06930755 — Study of NMS-03305293 in Adult Patients With Relapsed Ovarian Cancer · Phase 1 · recruiting
- NCT07318558 — A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021) · Phase 3 · recruiting
- NCT07491081 — EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection · NA · recruiting
- NCT07410676 — EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
Other The Affiliated Hospital of Xuzhou Medical University trials
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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 NCT05211557 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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 The Affiliated Hospital of Xuzhou Medical University
- Last refreshed: 27 January 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/NCT05211557.
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