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
- Conditions
- Primary Peritoneal CarcinomaFallopian Tube CancerEpithelial Ovarian Cancer
- Interventions
- Registration Number
- NCT06469281
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Former Sponsor 2seventy bio
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 90
- 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
Key
- Inadequate cardiovascular, renal and hepatic function, as described in the protocol
- Absolute lymphocyte count (ALC) < 100 cells/μL at time of leukapheresis
- History of Grade ≥ 2 hemorrhage within 30 days, or inadequate coagulation parameters, as described in the protocol
- Known history or presence of clinically relevant central nervous system (CNS) pathology, as described in the protocol
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Expansion - Arm C 27T51 27T51+Cemiplimab+Bevacizumab Dose Expansion - Arm A 27T51 27T51 monotherapy Dose Expansion - Arm B 27T51 27T51+Cemiplimab Dose Expansion - Arm C Bevacizumab 27T51+Cemiplimab+Bevacizumab Dose Escalation 27T51 27T51 monotherapy Dose Expansion - Arm C Cemiplimab 27T51+Cemiplimab+Bevacizumab Dose Expansion - Arm B Cemiplimab 27T51+Cemiplimab
- Primary Outcome Measures
Name Time Method Incidence of treatment emergent adverse events (TEAEs) Up to 18 months Part 1a
Incidence of adverse events of special interest (AESIs) Up to 18 months Part 1a
Incidence of adverse events of dose limiting toxicities (DLTs) Up to 18 months Part 1a
Manufacturing feasibility of 27T51 Up to 3 years Phase 1a/1b Determination of the feasibility of manufacturing 27T51 is measured by the percent of leukapheresis products collected that are able to be manufactured and released for infusion.
Overall response rate (ORR) as assessed by the investigator Up to 48 months Phase 1b
- Secondary Outcome Measures
Name Time Method ORR as assessed by the investigator Up to 48 months Phase 1a
Incidence of AESIs Up to 48 months Phase 1b
Incidence of DLTs Up to 48 months Phase 1b - Arms B and C
Incidence of TEAEs Up to 48 months Phase 1b
Duration of response (DoR) Up to 48 months Phase 1a/1b
Disease control rate (DCR) Up to 48 months Phase 1a/1b
Trial Locations
- Locations (4)
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