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RecruitingInterventionalPhase 1

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

NCT ID: NCT06469281Sponsor: Regeneron PharmaceuticalsLast updated: 2026-02-03

Summary

This study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer. This study has two (2) major parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51. Information collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.

Detailed description

Former Sponsor 2seventy bio

Arms & interventions

  • Other27T51

    Intravenous (IV) infusion

  • DrugCemiplimab

    IV infusion

  • DrugBevacizumab

    IV Infusion

Outcome measures

Primary

  • Incidence of treatment emergent adverse events (TEAEs)

    Part 1a

    Time frame: Up to 18 months

  • Incidence of adverse events of special interest (AESIs)

    Part 1a

    Time frame: Up to 18 months

  • Incidence of adverse events of dose limiting toxicities (DLTs)

    Part 1a

    Time frame: Up to 18 months

  • Manufacturing feasibility of 27T51

    Phase 1a/1b Determination of the feasibility of manufacturing 27T51 is measured by the percent of leukapheresis products collected that are able to be manufactured and released for infusion.

    Time frame: Up to 3 years

  • Overall response rate (ORR) as assessed by the investigator

    Phase 1b

    Time frame: Up to 48 months

Secondary

  • ORR as assessed by the investigator

    Time frame: Up to 48 months

  • Duration of response (DoR)

    Time frame: Up to 48 months

  • Disease control rate (DCR)

    Time frame: Up to 48 months

  • Incidence of TEAEs

    Time frame: Up to 48 months

  • Incidence of AESIs

    Time frame: Up to 48 months

  • Incidence of DLTs

    Time frame: Up to 48 months

Eligibility criteria

Sex: FemaleAge: 18 Years and olderHealthy volunteers: No
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 locations (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114

Recruiting
Oladapo Yeku, MD, FACP · Contact

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting
Oncology Clinical Research Referral Office · Contact

Roswell Park Cancer Institute

Buffalo, New York, 14203

Recruiting

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

LDS Hospital

Salt Lake City, Utah, 84143

Recruiting
Joshua Kunz · Contact