Actively Recruiting
MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer
Led by Mayo Clinic · Updated on 2026-03-16
12
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer
- Measurable disease with at least one lesion 1 cm or larger by CT, MRI, or PET/CT
- Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of platinum chemotherapy
- Patients with BRCA1/2 mutations must have received prior PARP inhibitor treatment
- Provide written informed consent
- Willing to provide mandatory blood specimens and biopsy tissue for research
- ECOG performance status of 0 or 1
- Histologically confirmed epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease
- MUC1 expression in tumor cells confirmed by immunohistochemistry
- Expected survival greater than 6 months and less than 24 months
- Willing and able to provide written informed consent
- Willing to return to Mayo Clinic in Arizona for follow-up
- Willing to undergo leukapheresis
- Adequate blood counts and organ function within 14 days prior to registration
- Negative pregnancy test within 7 days prior to registration
You will not qualify if you...
- Clinically unresolved central nervous system metastases
- Prior treatment targeting MUC1
- Known plasma cell leukemia
- Pregnant or nursing persons, or persons unwilling to use adequate birth control
- Recent myocardial infarction or congestive heart failure requiring ongoing treatment
- Failure to recover to baseline from prior therapy except stable grade 2 peripheral neuropathy
- Uncontrolled illness including infection, symptomatic heart failure, unstable angina, psychiatric problems, lack of caregiver support, or oxygen dependency at rest
- Immunocompromised status or HIV positive on therapy
- Chronic high-dose steroid use
- Receiving other investigational cancer treatments
- Active malignancy documented within 4 years except certain skin or cervical cancers
- Active autoimmune disease requiring systemic treatment within 30 days prior to pre-registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
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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