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
NCT ID: NCT06469281
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
90 participants
INTERVENTIONAL
2024-08-06
2030-05-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
27T51 monotherapy
27T51
Intravenous (IV) infusion
Dose Expansion - Arm A
27T51 monotherapy
27T51
Intravenous (IV) infusion
Dose Expansion - Arm B
27T51+Cemiplimab
27T51
Intravenous (IV) infusion
Cemiplimab
IV infusion
Dose Expansion - Arm C
27T51+Cemiplimab+Bevacizumab
27T51
Intravenous (IV) infusion
Cemiplimab
IV infusion
Bevacizumab
IV Infusion
Interventions
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27T51
Intravenous (IV) infusion
Cemiplimab
IV infusion
Bevacizumab
IV Infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Oladapo Yeku, MD, FACP
Role: primary
Role: primary
Other Identifiers
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27T51-01
Identifier Type: -
Identifier Source: org_study_id
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