Phase I Clinical Trial of Autologous Folate Receptor-Alpha Redirected T Cells in Patients With FRa+ Cancers
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.
Arms & interventions
- BiologicalMOv19-BBz CAR T cells
Autologous T cells engineered to express an extracellular single chain variable fragment (scFv) with FRa specificity.
- DrugCyclophosphamide/Fludarabine
Cytotoxic chemotherapy agents used for lymphodepletion prior to MOv19-BBz CAR T cell administration.
- DeviceFRa Expression Testing
Laboratory Developed Test used to determine subject eligibility
Outcome measures
Primary
Incidence of adverse events as assessed by CTCAE V5.0
Type, frequency, severity, and attribution of adverse events.
Time frame: Up to 15 years post-MOv19-BBz CAR T cell administration
Occurrence of treatment-limiting toxicities (TLTs)
Unacceptable toxicity as defined by the protocol.
Time frame: 28 days post-MOv19-BBz CAR T cell administration
Secondary
Evaluate study feasibility
Time frame: 6 months
Objective Response Rate (ORR)
Time frame: Up to 12 months following treatment with MOv19-BBz CAR T cells
Duration of Response (DOR)
Time frame: Up to 15 years following treatment with MOv19-BBz CAR T cells
Progression Free Survival (PFS)
Time frame: Up to 15 years following treatment with MOv19-BBz CAR T cells
Overall Survival (OS)
Time frame: Up to 15 years following treatment with MOv19-BBz CAR T cell
Eligibility criteria
Study locations (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104