drugset / Trial / NCT04836507
Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients
NaSingle-groupOpen-labelTreatment
Summary
This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma and B-cell Acute Lymphoblastic Leukemia.
Timeline
- Start
- 2021-03-02
- Primary completion
- 2030-08-15
- Completion
- 2030-09-26
Publications
- Kim WS, Kim SJ, Yoon DH, Cho H, Yoon SE, Yang DH, Shin HJ, Eom HS, Lee E, Byun JM, Koh Y, Lee H, Jung J, Yoon SS, Song GY, Kim DY, Hong J, Park Y, Han S, Cho SH. Anbalcabtagene autoleucel (PD-1 and TIGIT knockdown CD19 CAR-T) for relapsed/refractory large B-cell lymphoma (CRC01-01). Blood. 2026 Jun 12:blood.2025032636. doi: 10.1182/blood.2025032636. Online ahead of print.
- Lee YH, Lee HJ, Kim HC, Lee Y, Nam SK, Hupperetz C, Ma JSY, Wang X, Singer O, Kim WS, Kim SJ, Koh Y, Jung I, Kim CH. PD-1 and TIGIT downregulation distinctly affect the effector and early memory phenotypes of CD19-targeting CAR T cells. Mol Ther. 2022 Feb 2;30(2):579-592. doi: 10.1016/j.ymthe.2021.10.004. Epub 2021 Oct 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anbalcabtagene autoleucel | Cell therapy | 1.5 cells/kg | Intravenous |
| Subject | Anbalcabtagene autoleucel | Cell therapy | 2 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |