Clinical trial NCT06469281: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Keywords: Ovarian Cancer
CAR T
Peritoneal
Fallopian Tube
MUC16
Immunotherapy
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-06-21
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Eligibility 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/Exclusion criteria apply

Primary outcomes:
measure: Incidence of treatment emergent adverse events (TEAEs)
timeFrame: Up to 18 months
measure: Incidence of adverse events of special interest (AESIs)
timeFrame: Up to 18 months
measure: Incidence of adverse events of dose limiting toxicities (DLTs)
timeFrame: Up to 18 months
measure: Manufacturing feasibility of 27T51
timeFrame: Up to 3 years
measure: Overall response rate (ORR) as assessed by the investigator
timeFrame: Up to 48 months
Secondary outcomes:
measure: ORR as assessed by the investigator
timeFrame: Up to 48 months
measure: Duration of response (DoR)
timeFrame: Up to 48 months
measure: Disease control rate (DCR)
timeFrame: Up to 48 months
measure: Incidence of TEAEs
timeFrame: Up to 48 months
measure: Incidence of AESIs
timeFrame: Up to 48 months
measure: Incidence of DLTs
timeFrame: Up to 48 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Hackensack
country: United States
facility: John Theurer Cancer Center Hackensack University Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: