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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Epithelial Ovarian Cancer
• Primary Peritoneal Carcinoma
• Fallopian Tube Cancer

Interventions

Type	Name	Description
OTHER	27T51	Intravenous (IV) infusion
DRUG	Cemiplimab	IV infusion
DRUG	Bevacizumab	IV Infusion

Timeline

• Start date: 2024-08-06
• Primary completion: 2030-05-27
• Completion: 2030-05-27
• First posted: 2024-06-21
• Last updated: 2026-02-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study