Recruiting
Phase 1

27T51

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06469281

Conditions

Epithelial Ovarian Cancer

Primary Peritoneal Carcinoma

Fallopian Tube Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

27T51

Cemiplimab

Bevacizumab

Study Details

Brief 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.

Conditions

Epithelial Ovarian Cancer

Primary Peritoneal Carcinoma

Fallopian Tube Cancer

Study ID

NCT06469281

Start date

Aug 6, 2024

Status verified date

Jan, 2026

Completion date

May 27, 2030

Anticipated

Primary completion date

May 27, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

27T51 monotherapy

experimental: Dose Expansion - Arm A

27T51 monotherapy

experimental: Dose Expansion - Arm B

27T51+Cemiplimab

experimental: Dose Expansion - Arm C

27T51+Cemiplimab+Bevacizumab

Interventions

27T51

Intravenous (IV) infusion

Cemiplimab

IV infusion

Bevacizumab

IV Infusion

Primary outcome measure

  • Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 18 months ]
  • Incidence of adverse events of special interest (AESIs) [ Time Frame: Up to 18 months ]
  • Incidence of adverse events of dose limiting toxicities (DLTs) [ Time Frame: Up to 18 months ]
  • Manufacturing feasibility of 27T51 [ Time Frame: Up to 3 years ]
  • Overall response rate (ORR) as assessed by the investigator [ Time Frame: Up to 48 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Oladapo Yeku, MD, FACP

617-643-9354

John Theurer Cancer Center Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777OncologyResearchReferral@hmhn.org

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14203

Contacts

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

LDS Hospital

Recruiting

Salt Lake City, Utah, United States, 84143

Contacts

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Feb 3, 2026

Last verified

Jan, 2026

Keywords

  • Ovarian Cancer
  • CAR T
  • Peritoneal
  • Fallopian Tube
  • MUC16
  • Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-02-03.