drugset / Trial / NCT03874897
Chimeric Antigen Receptor T Cells Targeting claudin18.2 in Solid Tumors.
Non-randomizedSingle-groupOpen-labelTreatment
Summary
An open label, single/multiple dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-claudin18.2 chimeric antigen receptor T cell in advanced solid tumor.
Timeline
- Start
- 2019-03-26
- Primary completion
- 2021-03-20
- Completion
- 2024-01-26
Publications
- Li J, Liu L, Tao M, Han Z, Ma M, Jiang L, Liu C, Liu D, Zhang P, Zhang M, Xue R, Gong J, Zhang X, Shen L, Qi C. Impact of concomitant medications on efficacy of CLDN18.2-specific CAR-T cell therapy in advanced gastric cancer. Br J Cancer. 2026 Feb;134(3):439-446. doi: 10.1038/s41416-025-03289-7. Epub 2025 Nov 29.
- Li J, Tao M, Liu L, Liu C, Ma M, Liu D, Zhang P, Zhang M, Xue R, Gong J, Zhang C, Zhang X, Shen L, Qi C. Peripheral blood neutrophils contribute to Claudin18.2-specific CAR-T cell treatment resistance in advanced gastric cancer. Br J Cancer. 2025 Jun;132(12):1167-1176. doi: 10.1038/s41416-025-03015-3. Epub 2025 Apr 17.
- Qi C, Liu C, Gong J, Liu D, Wang X, Zhang P, Qin Y, Ge S, Zhang M, Peng Z, Zhou J, Lu Z, Lu M, Cao Y, Yuan J, Wang Y, Wang Z, Xue R, Peng X, Wang Y, Yuan D, Li J, Zhang X, Shen L. Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial final results. Nat Med. 2024 Aug;30(8):2224-2234. doi: 10.1038/s41591-024-03037-z. Epub 2024 Jun 3.
- Qi C, Zhang P, Liu C, Zhang J, Zhou J, Yuan J, Liu D, Zhang M, Gong J, Wang X, Li J, Zhang X, Li N, Peng X, Liu Z, Yuan D, Baffa R, Wang Y, Shen L. Safety and Efficacy of CT041 in Patients With Refractory Metastatic Pancreatic Cancer: A Pooled Analysis of Two Early-Phase Trials. J Clin Oncol. 2024 Jul 20;42(21):2565-2577. doi: 10.1200/JCO.23.02314. Epub 2024 May 24.
- Qi C, Xie T, Zhou J, Wang X, Gong J, Zhang X, Li J, Yuan J, Liu C, Shen L. CT041 CAR T cell therapy for Claudin18.2-positive metastatic pancreatic cancer. J Hematol Oncol. 2023 Sep 9;16(1):102. doi: 10.1186/s13045-023-01491-9.
- Qi C, Gong J, Li J, Liu D, Qin Y, Ge S, Zhang M, Peng Z, Zhou J, Cao Y, Zhang X, Lu Z, Lu M, Yuan J, Wang Z, Wang Y, Peng X, Gao H, Liu Z, Wang H, Yuan D, Xiao J, Ma H, Wang W, Li Z, Shen L. Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial interim results. Nat Med. 2022 Jun;28(6):1189-1198. doi: 10.1038/s41591-022-01800-8. Epub 2022 May 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Satricabtagene autoleucel | Cell therapy | 2.5e+08 cells | Other |
| Subject | Satricabtagene autoleucel | Cell therapy | 3.75e+08 cells | Other |
| Subject | Satricabtagene autoleucel | Cell therapy | 5e+08 cells | Other |
| Subject | Toripalimab | Monoclonal antibody | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |