Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
Conditions
Keywords
Ovarian Cancer, CAR T, Peritoneal, Fallopian Tube, MUC16, Immunotherapy
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
Interventions
OTHER27T51
Intravenous (IV) infusion
DRUGCemiplimab
IV infusion
DRUGBevacizumab
IV Infusion
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion 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 Key
Exclusion criteria
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 Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| ORR as assessed by the investigator | Up to 48 months | Phase 1a |
| Duration of response (DoR) | Up to 48 months | Phase 1a/1b |
| Disease control rate (DCR) | Up to 48 months | Phase 1a/1b |
| Incidence of TEAEs | Up to 48 months | Phase 1b |
| Incidence of AESIs | Up to 48 months | Phase 1b |
| Incidence of DLTs | Up to 48 months | Phase 1b - Arms B and C |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed