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

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: Not yet recruiting
• Conditions: Fallopian Tube Cancer; Epithelial Ovarian Cancer; Primary Peritoneal Carcinoma
• Intervention / Treatment: Drug: Cemiplimab; Drug: Bevacizumab; Other: 27T51

Detailed Description

Former Sponsor 2seventy bio

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Administrator; Phone Number: 844-734-6643; Email: clinicaltrials@regeneron.com

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • John Theurer Cancer Center Hackensack University Medical Center
      • Contact: Suzanne Kosky; Phone Number: 551-996-3986; Email: Suzanne.Kosky@hmhn.org

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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)	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regeneron Pharmaceuticals
• Investigators: Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): June 29, 2029

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): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Immunotherapy; Ovarian Cancer; CAR T; Peritoneal; Fallopian Tube; MUC16
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Fallopian Tube Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Cemiplimab
• 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, has made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has 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