Trials / Recruiting
RecruitingNCT07116057
MOv19-BBz CAR T Cells in FRa+ Cancers
Phase I Clinical Trial of Autologous Folate Receptor-Alpha Redirected T Cells in Patients With FRa+ Cancers
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- University of Pennsylvania · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MOv19-BBz CAR T cells | Autologous T cells engineered to express an extracellular single chain variable fragment (scFv) with FRa specificity. |
| DRUG | Cyclophosphamide/Fludarabine | Cytotoxic chemotherapy agents used for lymphodepletion prior to MOv19-BBz CAR T cell administration. |
| DEVICE | FRa Expression Testing | Laboratory Developed Test used to determine subject eligibility |
Timeline
- Start date
- 2025-10-07
- Primary completion
- 2040-10-01
- Completion
- 2040-10-01
- First posted
- 2025-08-11
- Last updated
- 2025-10-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07116057. Inclusion in this directory is not an endorsement.