drugset / Trial / NCT06830031
Clinical Study of C402-CD19-CAR Treatment in Subjects With Relapsed or Refractory B-cell Lymphoma
Phase 1
Recruiting
18 enrolled
Shanghai Exuma Biotechnology Ltd.
Institute of Hematology & Blood Diseases Hospital, China · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is to investigate the safety and tolerability of C402-CD19-CAR treatment in subjects with relapsed or refractory large B-cell lymphoma and further determine the recommended Phase 2 dose of C402-CD19-CAR.
Timeline
- Start
- 2025-03-19
- Primary completion
- 2026-03-09
- Completion
- 2026-05-11
Publications
- Results Liu W, Liu J, Song Y, Zeng X, Wang X, Mi L, Cai C, Wang L, Ma J, Zhu J; Union for China Leukemia Investigators of the Chinese Society of Clinical Oncology; Union for China Lymphoma Investigators of the Chinese Society of Clinical Oncology. Burden of lymphoma in China, 2006-2016: an analysis of the Global Burden of Disease Study 2016. J Hematol Oncol. 2019 Nov 19;12(1):115. doi: 10.1186/s13045-019-0785-7.
- Results Liu W, Liu J, Song Y, Wang X, Mi L, Cai C, Zhao D, Wang L, Ma J, Zhu J. Burden of lymphoma in China, 1990-2019: an analysis of the global burden of diseases, injuries, and risk factors study 2019. Aging (Albany NY). 2022 Apr 10;14(7):3175-3190. doi: 10.18632/aging.204006. Epub 2022 Apr 10.
- Results Zahid U, Akbar F, Amaraneni A, Husnain M, Chan O, Riaz IB, McBride A, Iftikhar A, Anwer F. A Review of Autologous Stem Cell Transplantation in Lymphoma. Curr Hematol Malig Rep. 2017 Jun;12(3):217-226. doi: 10.1007/s11899-017-0382-1.
- Results Li X, Ding Y, Zi M, Sun L, Zhang W, Chen S, Xu Y. CD19, from bench to bedside. Immunol Lett. 2017 Mar;183:86-95. doi: 10.1016/j.imlet.2017.01.010. Epub 2017 Jan 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | C402-CD19-CAR | Cell therapy | 30000 cells/kg | Subcutaneous |
| Subject | C402-CD19-CAR | Cell therapy | 100000 cells/kg | Subcutaneous |
| Subject | C402-CD19-CAR | Cell therapy | 300000 cells/kg | Subcutaneous |