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
Apply to this trial

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

First listed
Aug 11, 2025
Start date
Oct 7, 2025
Status verified
Jun 2026
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

Find similar trials in Philadelphia, PA

By research site
University of Pennsylvania· Philadelphia, PA

Related Studies