drugset / Trial / NCT07679919
BAFF CAR-T Cells (LMY-922) for Treatment of Refractory Hematologic Malignancies
Non-randomizedSequentialOpen-labelTreatment
Summary
Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against refractory hematologic malignancies, 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 hematologic malignancies, 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 refractory hematologic malignancies using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process.
Timeline
- Start
- 2026-09
- Primary completion
- 2029-04
- Completion
- 2029-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LMY-922 | Cell therapy | 75 cells | — |
| Subject | LMY-922 | Cell therapy | 150 cells | — |
| Subject | LMY-922 | Cell therapy | 300 cells | — |
| Subject | LMY-922 | Cell therapy | 450 cells | — |