A Phase 1 Study to Evaluate TAG72-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced Epithelial Ovarian Cancer
City of Hope Medical Center
Summary
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.
Description
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/…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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. * Age \> 18 years. * 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).…
Interventions
- BiologicalChimeric Antigen Receptor T-cells
Receive TAG72-CAR T cells IP
- DrugCyclophosphamide
Given IV
- DrugFludarabine
Given IV
Location
- City of Hope Medical CenterDuarte, California