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

Purpose

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

  • Epithelial Ovarian Cancer
  • Primary Peritoneal Carcinoma
  • Fallopian Tube Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Other: 27T51
    Intravenous (IV) infusion
  • Drug: Cemiplimab
    IV infusion
    Other names:
    • Libtayo
    • REGN2810
Experimental
Dose Expansion - Arm C 		27T51+Cemiplimab+Bevacizumab
  • Other: 27T51
    Intravenous (IV) infusion
  • Drug: Cemiplimab
    IV infusion
    Other names:
    • Libtayo
    • REGN2810
  • Drug: Bevacizumab
    IV Infusion
    Other names:
    • Avastin
    • Mvasi
    • Vegzelma
    • Zirabe

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Oladapo Yeku, MD, FACP

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com

Detailed Description

Former Sponsor 2seventy bio