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

Trial Title: 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

NCT ID: NCT06469281

Condition: Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer

Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Bevacizumab
Cemiplimab

Conditions: Keywords:
Ovarian Cancer
CAR T
Peritoneal
Fallopian Tube
MUC16
Immunotherapy

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: 27T51
Description: Intravenous (IV) infusion
Arm group label: Dose Escalation
Arm group label: Dose Expansion - Arm A
Arm group label: Dose Expansion - Arm B
Arm group label: Dose Expansion - Arm C

Intervention type: Drug
Intervention name: Cemiplimab
Description: IV infusion
Arm group label: Dose Expansion - Arm B
Arm group label: Dose Expansion - Arm C

Other name: Libtayo

Other name: REGN2810

Intervention type: Drug
Intervention name: Bevacizumab
Description: IV Infusion
Arm group label: Dose Expansion - Arm C

Other name: Avastin

Other name: Mvasi

Other name: Vegzelma

Other name: Zirabe

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

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: John Theurer Cancer Center Hackensack University Medical Center

Address:
City: Hackensack
Zip: 07601
Country: United States

Status: Recruiting

Contact:
Last name: Suzanne Kosky

Phone: 551-996-3986
Email: Suzanne.Kosky@hmhn.org

Start date: July 18, 2024

Completion date: June 29, 2029

Lead sponsor:
Agency: Regeneron Pharmaceuticals
Agency class: Industry

Source: Regeneron Pharmaceuticals

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06469281