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

Last updated: April 11, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Recruiting

Phase

1

Condition

Ovarian Cysts

Fallopian Tube Cancer

Pelvic Cancer

Treatment

Cemiplimab

Bevacizumab

27T51

Clinical Study ID

NCT06469281
27T51-01
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

  2. Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tubecancer according to World of Health Organization (WHO) 2020 classification

  3. Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tubecancer, as described in the protocol

  4. Serum cancer antigen (CA) 125 ≥ 2 × upper limit of normal (ULN) as assessed at thelocal lab by a 510(k) cleared test at screening

  5. Participants must have at least 1 measurable tumor lesion as defined by the responseevaluation criteria in solid tumors (RECIST) 1.1.

  6. Expected survival ≥ 3 months

Exclusion

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 coagulationparameters, 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 thatrequired treatment with systemic immunosuppressive treatments, which may suggestrisk for immune related adverse events (AEs)

  6. Treatment with any cellular or gene therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Total Participants: 90
Treatment Group(s): 3
Primary Treatment: Cemiplimab
Phase: 1
Study Start date:
July 18, 2024
Estimated Completion Date:
June 29, 2029

Study Description

Former Sponsor 2seventy bio

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York 14203
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

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