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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGIncidence 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
Evaluate study feasibility
The proportion of enrolled subjects who are confirmed eligible and who receive study treatment as planned.
Time frame: 6 months
Objective Response Rate (ORR)
Proportion of subjects with confirmed CR or PR per RECIST 1.1 criteria.
Time frame: Up to 12 months following treatment with MOv19-BBz CAR T cells
Duration of Response (DOR)
Time from the date when confirmed CR or PR is first met, to the date of confirmed progressive disease, death due to any cause, or receipt of alternative anticancer therapy (excluding commercial immune checkpoint inhibitors as described by the study protocol); or it will be censored at the date of the last adequate assessment (whichever occurs first).
Time frame: Up to 15 years following treatment with MOv19-BBz CAR T cells
Progression Free Survival (PFS)
Duration from study treatment to disease progression, receipt of alternative anti-cancer therapy, or death.
Time frame: Up to 15 years following treatment with MOv19-BBz CAR T cells
Overall Survival (OS)
Duration of time from study treatment to the date of death, for any reason.
Time frame: Up to 15 years following treatment with MOv19-BBz CAR T cell
Abramson Cancer Center Clinical Trials Service
CONTACT
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