Immune cell therapy for recurrent ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates an experimental CAR T cell therapy called 27T51, designed to target the MUC16 protein in adult women with recurrent or treatment-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers. The trial consists of two main parts: a Phase 1a dose escalation to assess safety and determine the maximum tolerated dose, followed by a Phase 1b dose expansion to evaluate the efficacy of 27T51, potentially in combination with other medications. The goal is to gather data on the safety and effectiveness of this innovative immune cell therapy for solid tumors.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
2. Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
3. Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
4. Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at the local lab by a 510(k) cleared test at screening
5. Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.
6. Expected survival ≥ 3 months

Key Exclusion Criteria:

1. Inadequate cardiovascular, renal and hepatic function, as described in the protocol
2. Absolute lymphocyte count (ALC) \< 100 cells/μL at time of leukapheresis
3. History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
4. Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
5. Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune related adverse events (AEs)
6. Treatment with any cellular or gene therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• John Theurer Cancer Center Hackensack University Medical Center
  Hackensack, New Jersey, United States Recruiting
• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting
• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting
• LDS Hospital
  Salt Lake City, Utah, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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• Dual-target CAR-NK Cells for Peritoneal Cancers of the Ovary, Fallopian Tube, or Pseudoperitoneal Disease

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• Dual-target CAR-NK therapy for recurrent ovarian, fallopian tube, or primary peritoneal cancer

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.