CELL INTELLIGENCE · 肿瘤细胞治疗研究

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/Exclusion criteria apply

主要终点：Incidence of treatment emergent adverse events (TEAEs) · Part 1a · Up to 18 months；Incidence of adverse events of special interest (AESIs) · Part 1a · Up to 18 months；Incidence of adverse events of dose limiting toxicities (DLTs) · Part 1a · Up to 18 months；Manufacturing feasibility of 27T51 · 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. · Up to 3 years；Overall response rate (ORR) as assessed by the investigator · Phase 1b · Up to 48 months
次要终点：ORR as assessed by the investigator；Duration of response (DoR)；Disease control rate (DCR)；Incidence of TEAEs；Incidence of AESIs；Incidence of DLTs

• Dose Escalation · EXPERIMENTAL · 27T51 monotherapy
• Dose Expansion - Arm A · EXPERIMENTAL · 27T51 monotherapy
• Dose Expansion - Arm B · EXPERIMENTAL · 27T51+Cemiplimab
• Dose Expansion - Arm C · EXPERIMENTAL · 27T51+Cemiplimab+Bevacizumab

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.