Actively Recruiting
Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer
Led by Mayo Clinic ยท Updated on 2026-03-16
12
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying autologous MUC1-activated T cells in patients with relapsed or resistant ovarian cancer that expresses the MUC1 protein. This phase I trial aims to find the safest dose and evaluate preliminary effects of these T cells, which are made from the patient's own blood cells and designed to target tumor cells. The study also explores the immune response, safety, and feasibility of producing and administering these cells in this patient population. Participants undergo a dose-escalation treatment process starting with leukapheresis to collect blood cells, followed by chemotherapy with cyclophosphamide or bendamustine given intravenously over several days. Then they receive the MUC1-activated T cells through an IV infusion on day 0 or on days 0 and 21. The trial includes monitoring with echocardiography or MUGA scans, blood tests, and imaging such as CT, MRI, or PET/CT as needed. Ascites samples may also be collected during treatment and follow-up. During the study, participants will have follow-up visits at 30 and 60 days after day 28, then every three months for up to two years. Assessments include blood samples, imaging scans, and evaluations of side effects, immune responses, and tumor changes. Researchers will measure dose-limiting toxicities, maximum tolerated dose, and objective response rates. Safety monitoring includes checking for neurotoxicity and cytokine release syndrome. Hospital resource use and health economics will also be assessed throughout the study.
CONDITIONS
Brief 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 imaging or ruler for skin lesions
- Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior platinum chemotherapy
- Patients with BRCA1/2 mutations must have prior PARP inhibitor treatment
- Provide written informed consent
- Willingness to provide mandatory blood specimens and biopsy tissue
- ECOG performance status 0 or 1
- Histologic confirmation of MUC1-expressing tumor cells by immunohistochemistry
- Expected survival greater than 6 months but less than 24 months
- Willing and able to provide written informed consent
- Willing to return for follow-up at Mayo Clinic in Arizona
- 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...
- Unresolved central nervous system metastases or unstable brain metastases
- Prior treatment targeting MUC1
- Known plasma cell leukemia
- Pregnant or nursing persons, or those unwilling to use birth control
- Recent myocardial infarction or congestive heart failure requiring ongoing treatment
- Failure to recover from prior treatment effects except stable grade 2 neuropathy
- Uncontrolled illnesses including active infections, unstable angina, psychiatric problems, or lack of caregiver
- Immunocompromise or HIV positivity with antiretroviral therapy
- Chronic high-dose steroid use
- Use of other investigational cancer treatments
- Other active malignancies within 4 years except certain skin or cervical cancers
- Active autoimmune disease requiring systemic treatment within past 30 days (some exceptions 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 screening and enrollment visit including echocardiography (ECHO) or multigated acquisition scan (MUGA)
Duration - Up to 14 days after registration for leukapheresis; chemotherapy given on days -5 to -3 or -5 and -4
Participants undergo leukapheresis to collect blood cells for T cell manufacturing, followed by lymphodepleting chemotherapy with cyclophosphamide or bendamustine.
1 leukapheresis session (approximately 4 hours) and 3 to 4 chemotherapy infusions
Duration - Day 0 or days 0 and 21
Participants receive infusions of autologous MUC1-activated T cells to treat ovarian cancer.
1 or 2 intravenous T cell infusion visits lasting 10 to 60 minutes each
Duration - Up to 28 days after T cell infusion for dose-limiting toxicity assessment
Participants are monitored for safety and effectiveness of the T cell treatment with imaging and blood sample collections.
Multiple visits including blood sample collections and possible imaging as clinically indicated
Duration - Up to 2 years after treatment
Participants are followed to assess long-term safety and treatment outcomes.
Visits at 30 and 60 days after day 28, then every 3 months for 2 years
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
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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