Phase 1 Study of 27T51 CAR T Cell Therapy Alone or With Other Drugs for Adult Women With Recurrent or Hard-to-Treat Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

What this Trial Is About

Researchers are evaluating an experimental immune cell therapy called 27T51 for adult female participants with recurrent or difficult-to-treat epithelial ovarian, primary peritoneal, or fallopian tube cancer. The study aims to assess the safety and potential effects of this CAR T cell therapy, which targets the MUC16 protein found on these tumors. The study includes two main parts dose escalation to find a safe dose and dose expansion to further test the therapy alone or combined with other medications. The study involves giving participants 27T51 through intravenous infusion, either alone or combined with drugs like Cemiplimab and Bevacizumab. The first part gradually increases the dose to identify the highest safe amount, while the second part treats participants at that dose level in different groups. These groups receive 27T51 alone or in combination with one or both of the other drugs to explore various treatment approaches. Participants will be monitored closely for side effects, treatment responses, and the therapys manufacturing feasibility over up to 48 months. Researchers will collect data on adverse events, tumor responses, and disease control using scans and lab tests. Safety follow-up will last up to 18 months, with longer observation for response and manufacturing outcomes. This comprehensive monitoring helps understand the therapys safety and activity in these cancers.

A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Therapy, Administered Alone or in Combination is Safe and How Well it Works for Adult Participants With Recurrent or Treatment Resistant Ovarian Cancers