Chimeric Antigen Receptor T-cells

PRIMARY OBJECTIVES: I. To evaluate the safety and tolerability of TAG72-CAR T cells in participants with recurrent epithelial ovarian cancer (EOC). II To determine the maximum tolerated dose (MTD). III. To identify the recommended phase 2 dose (RP2D). SECONDARY OBJECTIVES: I. Persistence of CAR T cells in blood and peritoneal cavity pre- and 28 days post-infusion. II. Response based on Immune-Related Response Criteria (irRC). III.

Estimate the 6 month progression free survival rate. IV. Estimate median overall survival. V. TAG72 expression on tumor cells by immunohistochemistry (IHC) and/or flow cytometry; VI. Describe the serum cytokine profile pre- and post-CAR T cell infusion to assess potential cytokine release syndrome (CRS) toxicity and CAR T cell effector function. EXPLORATORY OBJECTIVES: I.

This phase I trial tests the safety, side effects, and best dose of TAG72-chimeric antigen receptor (CAR) T cells in treating patients with epithelial ovarian cancer that remains despite treatment with platinum therapy (platinum resistant). T cells are infection fighting blood cells that can kill tumor cells.

The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize TAG72, a protein on the surface of tumor cells. These TAG72-specific T cells may help the body's immune system identify and kill TAG72+ cancer cells.

Live record on ClinicalTrials.gov →

• ELIGIBILITY CRITERIA 1.1 Inclusion Criteria
• Participant must have the ability to understand and the willingness to sign a written informed consent.
• Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable exceptions may be granted with Study PI approval.
• ECOG Performance status 0 - 2 or KPS ≥70%.
• Documented platinum resistant EOC (defined as disease that has progressed within six months of completing platinum therapy, or lack of response or disease progression while receiving the most recent platinum-based therapy, respectively). Progression may be determined radiographically (not RECIST) or by new onset of malignant pleural effusion. Participant may have at least 1 measurable lesion or disease measured by PCI at the time of surgery.
• Documented TAG72+ (\> 1% cells ≥ +1 intensity) tumor expression by IHC (MAb CC49) as evaluated by COH Pathology Core.

Inclusion criteria as written on the registry, trimmed. The full list, with exclusions, is on the live record.