RecruitingPhase 1NCT06483048

MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer

Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer


Sponsor

Mayo Clinic

Enrollment

12 participants

Start Date

Sep 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I trial tests the safety, side effects, best dose of MUC1-activated T cells in treating patients with ovarian cancer that has come back after a period of improvement (relapsed) or that remains despite treatment (resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and are made in a laboratory to recognize MUC1, a protein on the surface of tumor cells that plays a key role in tumor cell growth. These MUC1-activated T cells may help the body's immune system identify and kill MUC1 expressing ovarian tumor cells.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing MUC1-activated T cells — immune cells from your own blood that have been trained in a lab to recognize and attack a protein called MUC1 that is commonly found on ovarian cancer cells — in women with relapsed or treatment-resistant ovarian, fallopian tube, or primary peritoneal cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer - Your cancer has come back or stopped responding to treatment, including at least one prior platinum-based chemotherapy - You have measurable disease on scans - You are otherwise well enough to participate **You may NOT be eligible if...** - You have active brain metastases - You have severe autoimmune disease or immune deficiency - You are pregnant or breastfeeding - You have had prior cell therapy or gene therapy 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

BIOLOGICALAutologous MUC1-activated T-cells

Given IV

DRUGBendamustine

Given IV

PROCEDUREBiospecimen Collection

Undergo blood and possible ascites sample collection

PROCEDUREComputed Tomography

Undergo CT or PET/CT

DRUGCyclophosphamide

Given IV

PROCEDUREEchocardiography

Undergo ECHO

PROCEDURELeukapheresis

Undergo leukapheresis

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREMultigated Acquisition Scan

Undergo MUGA

PROCEDUREPositron Emission Tomography

Undergo PET/CT


Locations(1)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

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NCT06483048


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