drugset / Trial / NCT03528421
Assessment of Safety and Efficacy of IM19 for Relapsed or Refractory NHL Patients
Phase 1
Unknown
30 enrolled
Beijing Immunochina Medical Science & Technology Co., Ltd.
Peking University Cancer Hospital & Institute · collab
NaSingle-groupOpen-labelTreatment
Summary
n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.
Timeline
- Start
- 2018-05-22
- Primary completion
- 2020-04
- Completion
- 2020-05
Publications
- Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
- Ying Z, He T, Wang X, Zheng W, Lin N, Tu M, Xie Y, Ping L, Zhang C, Liu W, Deng L, Wu M, Feng F, Leng X, Du T, Qi F, Hu X, Ding Y, Lu XA, Song Y, Zhu J. Distribution of chimeric antigen receptor-modified T cells against CD19 in B-cell malignancies. BMC Cancer. 2021 Feb 25;21(1):198. doi: 10.1186/s12885-021-07934-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IM19 | Cell therapy | 300000 cells/kg | Other |
| Subject | IM19 | Cell therapy | 1e+06 cells/kg | Other |
| Subject | IM19 | Cell therapy | 3e+06 cells/kg | Other |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |