NCT06469281RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 6 Jun 2024
- Start date
- 6 Aug 2024
- Primary completion date
- 27 May 2030
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Ovarian cancer
- NCT number
- NCT06469281
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 90
- From 6 Aug 2024 to the primary completion date, 27 May 2030
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Treatment with any cellular or gene therapy
- Note: Other protocol-defined Inclusion/Exclusion criteria apply
Other illness
- History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
Lab values
- Absolute lymphocyte count (ALC) \< 100 cells/μL at time of leukapheresis
Other
- Inadequate cardiovascular, renal and hepatic function, as described in the protocol
- Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
Who the study is looking for
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Histological diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube cancer according to World of Health Organization (WHO) 2020 classification
- Recurrent or refractory epithelial ovarian, primary peritoneal, or fallopian tube cancer, as described in the protocol
- 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
- Participants must have at least 1 measurable tumor lesion as defined by the response evaluation criteria in solid tumors (RECIST) 1.1.
- Expected survival ≥ 3 months
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Roswell Park Cancer Institute Coordinator of this site? Confirm its status | Buffalo | United States | Recruiting |
| John Theurer Cancer Center, Hackensack University Medical Center Coordinator of this site? Confirm its status | Hackensack | United States | Recruiting |
| UPMC Hillman Cancer Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| LDS Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.