RecruitingPhase 1NCT07116057

MOv19-BBz CAR T Cells in FRa+ Cancers

Phase I Clinical Trial of Autologous Folate Receptor-Alpha Redirected T Cells in Patients With FRa+ Cancers


Sponsor

University of Pennsylvania

Enrollment

10 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase I open-label clinical trial to assess the safety, feasibility, and preliminary efficacy of intrapleural administration of MOv19-BBz CAR T cells in patients with FRa+ cancers. This study will be initiated in patients with metastatic or recurrent non-small cell lung cancer (NSCLC) only. Subjects will receive a single dose of MOv19-BBz CAR T cells via intrapleural infusion following lymphodepleting chemotherapy. Subjects without an existing intra-pleural catheter will have a temporary pleural catheter placed for the study. Subjects may initiate treatment with commercial checkpoint inhibitors per routine care beginning at least 28 days after receiving MOv19-BBz CAR T cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a special type of immune cell therapy called CAR T cells that are engineered to target a protein called folate receptor alpha (FRα), which is found on the surface of certain cancer cells. It is being studied in people with advanced lung cancer or other cancers that express this protein. **You may be eligible if...** - You are 18 or older - Your cancer has been tested and shows folate receptor alpha (FRα) expression on at least 10% of tumor cells - You have metastatic or recurrent lung adenocarcinoma with cancer fluid in the pleural space (around the lung) - You have already received at least one standard treatment for advanced disease - Your organ function (kidneys, liver, heart, lungs) meets minimum requirements **You may NOT be eligible if...** - Your cancer does not express the FRα protein - You have uncontrolled or symptomatic brain metastases - You are on dialysis or have significant liver disease - 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

BIOLOGICALMOv19-BBz CAR T cells

Autologous T cells engineered to express an extracellular single chain variable fragment (scFv) with FRa specificity.

DRUGCyclophosphamide/Fludarabine

Cytotoxic chemotherapy agents used for lymphodepletion prior to MOv19-BBz CAR T cell administration.

DEVICEFRa Expression Testing

Laboratory Developed Test used to determine subject eligibility


Locations(1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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NCT07116057


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