RecruitingPhase 1NCT07030907

A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer

A Phase 1a/b Study to Evaluate the Safety and Efficacy of OPB-101, an Autologous Mesothelin (MSLN) CAR T Cell Therapy With Antigen-dependent Expression of OUTSMART™ Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer


Sponsor

Outpace Bio, Inc.

Enrollment

30 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101. Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called OPB-101 in women with high-grade serous ovarian, fallopian tube, or primary peritoneal cancer that has come back within 6 months of platinum chemotherapy (known as platinum-resistant disease). **You may be eligible if:** - You are 18 or older - You have been diagnosed with high-grade serous ovarian, peritoneal, or fallopian tube cancer - Your cancer came back within 6 months of your last platinum-based chemotherapy - You have received at least 2 prior lines of chemotherapy - You received a PARP inhibitor if you have a BRCA1/2 gene mutation - You are in good physical health with adequate organ function **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have active, uncontrolled infection or autoimmune disease - You have received prior CAR-T cell therapy or mesothelin-targeted therapy - You have active brain metastases or significant lung, heart, or liver disease - You have received chemotherapy within the past 3 weeks 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALOPB-101

An autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine


Locations(4)

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Roswell Park

Buffalo, New York, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07030907


Related Trials