University of Pennsylvania
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.
Inclusion Criteria: 1. Signed informed consent form 2. Documentation of tumor FRa expression by IHC at the Hospital of the University of Pennsylvania (≥ 10% of tumor cells). Subjects must have archived tumor tissue available. 3. Disease-specific criteria: a. NSCLC Patients: i. Metastatic or recurrent lung adenocarcinoma with cytologically or pathologically confirmed malignant pleural effusion. ii. Failure of at least one prior line of standard of care therapy for advanced stage disease. 4. Patients must have evidence of active disease as defined by RECIST 1.1 criteria 5. Patients with…
Autologous T cells engineered to express an extracellular single chain variable fragment (scFv) with FRa specificity.
Cytotoxic chemotherapy agents used for lymphodepletion prior to MOv19-BBz CAR T cell administration.
Laboratory Developed Test used to determine subject eligibility
Arctuva estimate
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