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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Epithelial Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Hackensack

John Theurer Cancer Center Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Regeneron Pharmaceuticals,

Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

2029-06-29