Immune cell therapy for recurrent ovarian cancer
A Phase 1a/1b Study of 27T51, an Anti-MUC16 CAR T Cell Drug Product Administered Alone or in Combination for Participants With Recurrent or Refractory Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
This study is testing a new immune cell therapy called 27T51 to see if it can help women with recurrent ovarian cancer feel better and fight their disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | CAR T |
| Locations | 5 sites (Boston, Massachusetts and 4 other locations) |
| Trial ID | NCT06469281 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult women with recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer.
Not a fit: Patients with inadequate organ function or certain hematological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat ovarian cancers.
How similar studies have performed: Other studies using CAR T cell therapies have shown promise in treating various cancers, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.