MOv19-BBz CAR T Cells in aFR Expressing Recurrent High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT03585764 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2025-03-26
Summary
Phase I study to establish safety and feasibility of intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy
Conditions
Interventions
- DRUG
-
MOv19-BBz CAR T cells
intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy.
- DEVICE
-
Alpha Folate Receptor expression test
Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
OvaCure Fundation
collaborator UNKNOWN -
Alliance for Cancer Gene Therapy
collaborator OTHER -
Ovarian Cancer Alliance of Greater Cincinnati
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Payal D Shah, MD · University of Pennsylvania
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-10-24
- Primary Completion
- 2024-03-26
- Completion
- 2024-03-26
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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