RecruitingPhase 1NCT06469281

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


Sponsor

Regeneron Pharmaceuticals

Enrollment

90 participants

Start Date

Aug 6, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new immune cell therapy called 27T51, which targets a protein called MUC16 found on ovarian cancer cells. It is being studied alone and in combination with other drugs in women with recurrent or treatment-resistant ovarian, fallopian tube, or peritoneal cancer. **You may be eligible if...** - You have been diagnosed with epithelial ovarian, primary peritoneal, or fallopian tube cancer that has come back or stopped responding to treatment - Your cancer antigen CA-125 level is at least twice the upper limit of normal - You have at least one measurable tumor on a scan - Your ECOG performance score is 0 or 1 - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have inadequate heart, kidney, or liver function - You have had certain prior therapies that would disqualify you per protocol - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER27T51

Intravenous (IV) infusion

DRUGCemiplimab

IV infusion

DRUGBevacizumab

IV Infusion


Locations(5)

Massachusetts General Hospital

Boston, Massachusetts, United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

LDS Hospital

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

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NCT06469281


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