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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
NCT06469281 · Regeneron Pharmaceuticals
In plain English
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Official title
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
About this study
Former Sponsor 2seventy bio
Eligibility 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
Study design
Enrollment target: 90 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-08-06
Estimated completion: 2030-05-27
Last updated: 2026-02-03
Interventions
Other: 27T51Drug: CemiplimabDrug: Bevacizumab
Primary outcomes
- • Incidence of treatment emergent adverse events (TEAEs) (Up to 18 months)
- • Incidence of adverse events of special interest (AESIs) (Up to 18 months)
- • Incidence of adverse events of dose limiting toxicities (DLTs) (Up to 18 months)
Sponsor
Regeneron Pharmaceuticals · industry
Contacts & investigators
ContactClinical Trials Administrator · contact · clinicaltrials@regeneron.com · 844-734-6643
InvestigatorClinical Trial Management · study_director, Regeneron Pharmaceuticals
All locations (5)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
John Theurer Cancer Center Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Roswell Park Cancer InstituteRecruiting
Buffalo, New York, United States
UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
LDS HospitalRecruiting
Salt Lake City, Utah, United States