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NCT04562298
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian Cancer
Phase 1 trial testing LCAR-M23 cells in Epithelial Ovarian Cancer in 15 participants. Terminated before completion.
7 June 2022
Quick facts
| Lead sponsor | Shanghai East Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 21 October 2020 |
| Primary completion | 7 June 2022 |
| Estimated completion | 7 June 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- LCAR-M23 cells — full drug profile →
Conditions studied
- Epithelial Ovarian Cancer — all drugs for Epithelial Ovarian Cancer →
Sponsor
Shanghai East Hospital
Who can join
Adults 18 to 70, female only, with Epithelial Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a prospective, single-arm, open-label, single-dose dose finding and extension study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy profiles of the LCAR-M23 CAR-T cell therapy in subjects with relapsed and refractory epithelial ovarian cancer after prior adequate standard of care.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
CAR-T cell combination therapy: the next revolution in cancer treatment.
Al-Haideri M, Tondok SB, Safa SH, Maleki AH, et al · · 2022 · cited 106× · PMID 36419058 · DOI 10.1186/s12935-022-02778-6 -
Challenges of Anti-Mesothelin CAR-T-Cell Therapy.
Zhai X, Mao L, Wu M, Liu J, et al · · 2023 · cited 47× · PMID 36900151 · DOI 10.3390/cancers15051357 -
Barriers to Immunotherapy in Ovarian Cancer: Metabolic, Genomic, and Immune Perturbations in the Tumour Microenvironment.
Johnson RL, Cummings M, Thangavelu A, Theophilou G, et al · · 2021 · cited 33× · PMID 34944851 · DOI 10.3390/cancers13246231 -
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 -
Enhancing precision in cancer treatment: the role of gene therapy and immune modulation in oncology.
Youssef E, Fletcher B, Palmer D. · · 2024 · cited 20× · PMID 39871848 · DOI 10.3389/fmed.2024.1527600 -
Dominant-negative transforming growth factor-β receptor-armoured mesothelin-targeted chimeric antigen receptor T cells slow tumour growth in a mouse model of ovarian cancer.
Li K, Xu J, Wang J, Lu C, et al · · 2023 · cited 20× · PMID 36166071 · DOI 10.1007/s00262-022-03290-6 -
The role of cancer-associated mesothelial cells in the progression and therapy of ovarian cancer.
Zheng A, Wei Y, Zhao Y, Zhang T, et al · · 2022 · cited 18× · PMID 36268019 · DOI 10.3389/fimmu.2022.1013506 -
Immunotherapy and Its Development for Gynecological (Ovarian, Endometrial and Cervical) Tumors: From Immune Checkpoint Inhibitors to Chimeric Antigen Receptor (CAR)-T Cell Therapy.
Schepisi G, Casadei C, Toma I, Poti G, et al · · 2021 · cited 18× · PMID 33671294 · DOI 10.3390/cancers13040840
Verify or expand the search:
- PubMed search for NCT04562298
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Epithelial Ovarian Cancer
Currently open trials in the same condition.
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- NCT07480954 — Dual-Targeting CAR-NK Cells for Recurrent Ovarian Cancer (MSLN, FRα, MUC16) · Phase 1, PHASE2 · recruiting
- NCT07218809 — AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Can · Phase 3 · recruiting
- NCT07495397 — Single-arm, Prospective Clinical Trial of Efficacy and Safety of Daphnetin Capsules Combined With TC Regimen for Targete · NA · recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
Other Shanghai East Hospital trials
Trials by the same sponsor.
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- NCT07279259 — Thrombolysis in Early Acute Ischemic Stroke Trial-Blood Pressure Management · Phase 2 · recruiting
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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 NCT04562298 (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 Shanghai East Hospital
- Last refreshed: 18 August 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/NCT04562298.
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