MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ PRE-REGISTRATION: Age ≥ 18 years
- ✓ PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer
- ✓ PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET/CT
- ✓ Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler
- ✓ PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1/2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring \< 183 days after the last dose of platinum-based chemotherapy:
- ✓ Development of measurable disease (per RECIST 1.1)
- ✓ Progression of radiographic disease (per RECIST 1.1)
- ✓ Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits \[WNL\] at the completion of platinum-based chemotherapy)
You may not qualify if…
- ✕ Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for \> 30 days, and not requiring steroid therapy for \> 14 days
- ✕ Prior treatment targeting MUC1
- ✕ Subjects with known plasma cell leukemia (PCL)
- ✕ Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and/or teratogenic effects:
- ✕ Pregnant persons
- ✕ Nursing persons
- ✕ Persons of childbearing potential who are unwilling to employ adequate birth control measures
- ✕ History of myocardial infarction ≤ 6 months prior to registration, and/or congestive heart failure requiring ongoing treatment such as medications and/or an implanted defibrillator to control life-threatening arrhythmias
Where it's recruiting
Scottsdale
Source: ClinicalTrials.gov · NCT06483048 · last updated 2026-03-16