drugset / Trial / NCT07116057

MOv19-BBz CAR T Cells in FRa+ Cancers

NCT07116057 ↗

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

EvaluationDrugModalityDoseRoute
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 — —