drugset / Trial / NCT07116057
MOv19-BBz CAR T Cells in FRa+ Cancers
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I open-label clinical trial to assess the safety, feasibility, and preliminary efficacy of intrapleural administration of MOv19-BBz CAR T cells in patients with FRa+ cancers. This study will be initiated in patients with metastatic or recurrent non-small cell lung cancer (NSCLC) only. Subjects will receive a single dose of MOv19-BBz CAR T cells via intrapleural infusion following lymphodepleting chemotherapy. Subjects without an existing intra-pleural catheter will have a temporary pleural catheter placed for the study. Subjects may initiate treatment with commercial checkpoint inhibitors per routine care beginning at least 28 days after receiving MOv19-BBz CAR T cells.
Timeline
- Start
- 2025-10-07
- Primary completion
- 2040-10
- Completion
- 2040-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MOv19-BBz CAR T cells | Cell therapy | 2.5e+07 cells | Intrathecal |
| Subject | MOv19-BBz CAR T cells | Cell therapy | 5e+07 cells | Intrathecal |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |