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

January 30, 2026 updated by: Regeneron Pharmaceuticals

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Former Sponsor 2seventy bio

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
          • Oladapo Yeku, MD, FACP
          • Phone Number: 617-643-9354
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center Hackensack University Medical Center
        • Contact:
    • New York
      • Buffalo, New York, United States, 14203
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
    • Utah
      • Salt Lake City, Utah, United States, 84143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
27T51 monotherapy
Other: 27T51
Intravenous (IV) infusion
Experimental: Dose Expansion - Arm A
27T51 monotherapy
Other: 27T51
Intravenous (IV) infusion
Experimental: Dose Expansion - Arm B
27T51+Cemiplimab
Drug: Cemiplimab
IV infusion
Other Names:
  • REGN2810
  • Libtayo
Other: 27T51
Intravenous (IV) infusion
Experimental: Dose Expansion - Arm C
27T51+Cemiplimab+Bevacizumab
Drug: Cemiplimab
IV infusion
Other Names:
  • REGN2810
  • Libtayo
Drug: Bevacizumab
IV Infusion
Other Names:
  • Avastin
  • Mvasi
  • Vegzelma
  • Zirabe
Other: 27T51
Intravenous (IV) infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment emergent adverse events (TEAEs)
Time Frame: Up to 18 months
Part 1a
Up to 18 months
Incidence of adverse events of special interest (AESIs)
Time Frame: Up to 18 months
Part 1a
Up to 18 months
Incidence of adverse events of dose limiting toxicities (DLTs)
Time Frame: Up to 18 months
Part 1a
Up to 18 months
Manufacturing feasibility of 27T51
Time Frame: Up to 3 years
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.
Up to 3 years
Overall response rate (ORR) as assessed by the investigator
Time Frame: Up to 48 months
Phase 1b
Up to 48 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR as assessed by the investigator
Time Frame: Up to 48 months
Phase 1a
Up to 48 months
Duration of response (DoR)
Time Frame: Up to 48 months
Phase 1a/1b
Up to 48 months
Disease control rate (DCR)
Time Frame: Up to 48 months
Phase 1a/1b
Up to 48 months
Incidence of TEAEs
Time Frame: Up to 48 months
Phase 1b
Up to 48 months
Incidence of AESIs
Time Frame: Up to 48 months
Phase 1b
Up to 48 months
Incidence of DLTs
Time Frame: Up to 48 months
Phase 1b - Arms B and C
Up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2024

Primary Completion (Estimated)

May 27, 2030

Study Completion (Estimated)

May 27, 2030

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 19, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

February 3, 2026

Last Update Submitted That Met QC Criteria

January 30, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27T51-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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