Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Signed informed consent form

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.

Patients must have evidence of active disease as defined by RECIST 1.1 criteria

Patients with asymptomatic CNS metastases that have been treated (and are off steroids for the treatment of CNS disease) are allowed. They must meet the following criteria

Disqualifiers

Any clinically significant pleural effusion that cannot be drained with standard approaches.

Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and/or evidence of extensive bilateral parenchymal metastatic burden.Note: "Greater than lobar" = "in more than 1 lobe".

Patients with radiographic and/or clinical evidence of active radiation pneumonitis.

Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc.).

Trial design

Treatments tested in this trial

  • MOv19-BBz CAR T cells
  • Cyclophosphamide/Fludarabine
  • FRa Expression Testing

Treatment groups

10 Participants
are divided into 2 treatment groups

Locations

1
University of Pennsylvania19104, PhiladelphiaPennsylvania, United States

Sponsors and collaborators

University of Pennsylvania

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov