Safety and Efficacy of CT125A Cells for Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies
Summary
Current treatments for relapsed/refractory hematopoietic malignancies such as B-cell lymphomas (BCLs) and peripheral T-cell lymphomas (PTCLs) are far from satisfactory. CD5 is widely expressed in multiple subtypes of BCLs and PTCLs but rarely found in normal tissues except certain types of lymphocytes. Chimeric antigen receptor (CAR) T cells against CD5 offer another potential therapeutic option for patients with relapsed/refractory CD5 positive hematopoietic malignancies. In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ hematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR/Cas9 genome editing technology to prevent fratricide during CAR T cells manufacturing.
Timeline
- Start
- 2021-03
- Primary completion
- 2023-09
- Completion
- 2023-12
Publications
- Cheng J, Zhu L, Wu J, Zeng Y, Mao X, Ding S, Wang J, Xiao Y, Zhou X, Mu W, Zhu X. Efficacy and safety of autologous CD5-KO anti-CD5 CAR-T cells in relapsed/refractory CD5+ hematological malignancies. Cell Rep Med. 2026 Feb 17;7(2):102584. doi: 10.1016/j.xcrm.2026.102584. Epub 2026 Feb 2.
- Mu W, Zhang M, Hu G, Han Y, Mao X, Chen C, Shen K, Dai Z, Zhu X, Zhou X, Huang L, Ao Q, Xiao M. Case report: Differential diagnosis of highly amplified anti-CD5 CAR T cells and relapsed lymphoma cells in a patient with refractory ALK positive anaplastic large cell lymphoma. Front Immunol. 2023 Dec 8;14:1280007. doi: 10.3389/fimmu.2023.1280007. eCollection 2023.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CT125A cells | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | CT125A cells | Cell therapy | 2e+06 cells/kg | Intravenous |
| Subject | CT125A cells | Cell therapy | 3e+06 cells/kg | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |