MOv19-BBz CAR T Cells in FRa+ Cancers

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07116057
Phase
PHASE1
Status
Recruiting
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Conditions

  • Metastatic Non Small Cell Lung Cancer
  • Recurrent Lung Non-Small Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MOv19-BBz CAR T cells — BIOLOGICAL
    Autologous T cells engineered to express an extracellular single chain variable fragment (scFv) with FRa specificity.
  • Cyclophosphamide/Fludarabine — DRUG
    Cytotoxic chemotherapy agents used for lymphodepletion prior to MOv19-BBz CAR T cell administration.
  • FRa Expression Testing — DEVICE
    Laboratory Developed Test used to determine subject eligibility

Study Details

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.

Key Dates

Start date
Oct 7, 2025
Status verified
Oct 2025
Primary completion
Oct 31, 2040
Completion
Oct 31, 2040

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1 (DL1)
    single dose of 5x10(7) MOv19-BBz CAR T cells administered via intrapleural infusion following lymphodepleting chemotherapy
  • Experimental: Dose Level -1 (DL-1)
    2.5x10(7) MOv19-BBz CAR T cells adminstered via intrapleural infusion, following lymphodepleting chemotherapy. This dose level will only be explored if ≥ 2 TLTs occur at any time in DL1.

Primary Outcome Measure

Incidence of adverse events as assessed by CTCAE V5.0 [ Time Frame: Up to 15 years post-MOv19-BBz CAR T cell administration ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Abramson Cancer Center Clinical Trials Service
[email protected]
215-349-8245

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By research site
University of Pennsylvania· Philadelphia, PA

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