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

NCT06469281 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 27T51-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

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

Primary Peritoneal Carcinoma; Fallopian Tube Cancer; Epithelial Ovarian Cancer

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Incidence of treatment emergent adverse events (TEAEs)

  Part 1a

  Up to 18 months

• Incidence of adverse events of special interest (AESIs)

  Part 1a

  Up to 18 months

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

  Part 1a

  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.

  Up to 3 years

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

  Phase 1b

  Up to 48 months

Secondary Outcomes (6)

• ORR as assessed by the investigator

  Up to 48 months

• Duration of response (DoR)

  Up to 48 months

• Disease control rate (DCR)

  Up to 48 months

• Incidence of TEAEs

  Up to 48 months

• Incidence of AESIs

  Up to 48 months

Study Arms (4)

Dose Escalation

EXPERIMENTAL

27T51 monotherapy

Other: 27T51

Dose Expansion - Arm A

EXPERIMENTAL

27T51 monotherapy

Other: 27T51

Dose Expansion - Arm B

EXPERIMENTAL

27T51+Cemiplimab

Other: 27T51; Drug: Cemiplimab

Dose Expansion - Arm C

EXPERIMENTAL

27T51+Cemiplimab+Bevacizumab

Other: 27T51; Drug: Cemiplimab; Drug: Bevacizumab

Interventions

Bevacizumab DRUG

IV Infusion

Also known as: Avastin, Mvasi, Vegzelma, Zirabe

Dose Expansion - Arm C

27T51 OTHER

Intravenous (IV) infusion

Dose Escalation; Dose Expansion - Arm A; Dose Expansion - Arm B; Dose Expansion - Arm C

Cemiplimab DRUG

IV infusion

Also known as: Libtayo, REGN2810

Dose Expansion - Arm B; Dose Expansion - Arm C

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (5)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, 14203, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

LDS Hospital

Salt Lake City, Utah, 84143, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

cemiplimab; Bevacizumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 21, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): May 27, 2030
• Study Completion (Estimated): May 27, 2030
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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
• 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

Locations

US (5)