drugset / Trial / NCT05312801
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma
NaSequentialOpen-labelTreatment
Summary
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment. This phase 1 study will evaluate safe dose and provide initial signal of the activity of BAFF CAR-T cells against relapsed non-Hodgkin lymphoma using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.
Timeline
- Start
- 2023-11-21
- Primary completion
- 2025-05-01
- Completion
- 2025-09-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAFF CAR-T | Cell therapy | 1e+07 cells/kg | — |
| Subject | BAFF CAR-T | Cell therapy | 2e+07 cells/kg | — |
| Subject | BAFF CAR-T | Cell therapy | 4e+07 cells/kg | — |
| Subject | BAFF CAR-T | Cell therapy | 8e+07 cells/kg | — |