Actively Recruiting
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 OUTSMART21 Designed IL-2 Cytokine in Platinum-resistant Ovarian Cancer
Led by Outpace Bio, Inc. · Updated on 2025-12-18
30
Participants Needed
4
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and best dose of OPB-101, a new treatment for women with platinum-resistant ovarian cancer. This phase 1a/b clinical trial focuses on patients whose cancer has returned within six months after platinum-based chemotherapy and who have already received multiple prior treatments. The study uses a special type of therapy where a patient’s own T cells are modified in a lab to better fight cancer, specifically targeting mesothelin, a protein found on cancer cells. The treatment involves giving participants a one-time infusion of OPB-101, which is an autologous mesothelin CAR T cell therapy designed to express a specific IL-2 cytokine. Patients will be hospitalized to receive this infusion and then monitored closely at the clinical site over the following months. The study does not use a placebo and focuses solely on the experimental OPB-101 treatment. Participants will have regular safety checks, including laboratory tests and clinical evaluations, especially within the first 28 days and continuing up to two years after treatment. Researchers will assess how safe the therapy is over this time. The study requires participants to provide tumor tissue samples and undergo various health assessments like heart function tests, oxygen levels, and infection screening. The total participation time spans from the initial treatment day through extended follow-up visits for safety monitoring.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer
- Disease that has recurred within 6 months of last platinum-based therapy
- Received at least 2 prior lines of systemic chemotherapy including platinum-based chemotherapy
- Prior therapy with a PARP inhibitor if BRCA1/2 mutation is known
- Measurable disease
- Consent to provide archived tumor tissue sample
- ECOG performance status of 0 or 1
- Adequate organ function
- Alkaline phosphatase less than or equal to 2.5 times upper limit of normal
- Grade 1 or less dyspnea and oxygen saturation over 92% on room air
- Left ventricular ejection fraction 50% or higher
- Life expectancy of at least 3 months
- Adequate venous access
- Negative screen for infectious disease markers
- Negative serum pregnancy test
- Agree to abstain from heterosexual activity or use 2 forms of effective contraception
You will not qualify if you...
- Pregnant or breastfeeding women of child-bearing potential
- Uncontrolled bacterial, fungal, or viral infections
- Active infection requiring systemic therapy
- Bleeding or thrombotic disorders or at risk for severe hemorrhage
- Any form of primary immunodeficiency
- History of allogenic tissue or solid organ transplant
- Active autoimmune disease
- Use of systemic high dose corticosteroids
- Unresolved acute effects of prior therapy
- Active invasive cancer other than the study cancer
- Significant lung disease
- Clinically significant pericardial effusion
- Radiotherapy within 2 weeks before study intervention
- Major surgery within 28 days prior to enrollment
- Receipt of investigational agents or tumor vaccines
- Chemotherapy within 3 weeks before enrollment
- History of grade 3 or higher ascites
- Active central nervous system involvement
- Receipt of live vaccine within 30 days before study treatment
- Prior CAR T cell therapy
- Prior mesothelin targeted therapy
- Dependent on intravenous hydration or total parenteral nutrition. Note: Other protocol defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine.
Multiple visits during treatment period
Duration - Up to 2 years
Participants are monitored for safety and efficacy after treatment with OPB-101.
Regular visits during follow-up period
Trial Site Locations
Total: 4 locations
1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
2
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
3
Roswell Park
Buffalo, New York, United States, 14203
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
John Ferraro, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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