Actively Recruiting
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
Led by Regeneron Pharmaceuticals · Updated on 2026-02-03
90
Participants Needed
5
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Confirmed histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer
- Serum cancer antigen (CA) 125 at least 2 times the upper limit of normal at screening
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Expected survival of 3 months or longer
You will not qualify if you...
- Inadequate heart, kidney, or liver function as defined in the study protocol
- Absolute lymphocyte count below 100 cells/µL at leukapheresis
- History of Grade 2 or higher bleeding within 30 days or abnormal blood clotting parameters
- Known or suspected significant brain or central nervous system disorders
- Current or recent (within 2 years) significant autoimmune disease requiring systemic immunosuppressive treatment
- Prior treatment with cellular or gene therapy
- Other protocol-defined exclusion criteria apply
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
3
Roswell Park Cancer Institute
Buffalo, New York, United States, 14203
Actively Recruiting
4
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
LDS Hospital
Salt Lake City, Utah, United States, 84143
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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