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NCT Number: NCT06469281

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

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.

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Key information

About this study

Former Sponsor 2seventy bio

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
  • Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
  • 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
  • Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.
  • Expected survival ≥ 3 months

Key Exclusion Criteria:

  • Inadequate cardiovascular, renal and hepatic function, as described in the protocol
  • Absolute lymphocyte count (ALC) < 100 cells/μL at time of leukapheresis
  • History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
  • Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
  • 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)
  • Treatment with any cellular or gene therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Treatment and study plan

27T51

Other

Intravenous (IV) infusion

cemiplimab

Drug

IV infusion

Other names: Libtayo, REGN2810

Bevacizumab

Drug

IV Infusion

Other names: Avastin, Mvasi, Vegzelma, Zirabe

Primary outcomes

  1. Incidence of treatment emergent adverse events (TEAEs)

    Time frame: Up to 18 months

    Part 1a

  2. Incidence of adverse events of special interest (AESIs)

    Time frame: Up to 18 months

    Part 1a

  3. Incidence of adverse events of dose limiting toxicities (DLTs)

    Time frame: Up to 18 months

    Part 1a

  4. 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.

  5. Overall response rate (ORR) as assessed by the investigator

    Time frame: Up to 48 months

    Phase 1b

Secondary outcomes

  1. ORR as assessed by the investigator

    Time frame: Up to 48 months

    Phase 1a

  2. Duration of response (DoR)

    Time frame: Up to 48 months

    Phase 1a/1b

  3. Disease control rate (DCR)

    Time frame: Up to 48 months

    Phase 1a/1b

  4. Incidence of TEAEs

    Time frame: Up to 48 months

    Phase 1b

  5. Incidence of AESIs

    Time frame: Up to 48 months

    Phase 1b

  6. Incidence of DLTs

    Time frame: Up to 48 months

    Phase 1b - Arms B and C

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Jun 21, 2024
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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