MUC1-Activated T Cells for Relapsed/Resistant Ovarian Cancer
This study is testing the safety and best dose of MUC1-activated T cells for women with ovarian, fallopian tube, or primary peritoneal cancer that has returned or not responded to previous treatments. These T cells are your own infection-fighting cells, specially trained in a lab to recognize and attack cancer cells that have a protein called MUC1. You will receive these T cells intravenously (into a vein), along with other medications like Bendamustine and Cyclophosphamide. Researchers will also collect blood and possibly fluid samples, and you'll have CT or PET/CT scans. The main goals are to find a safe dose and see how many patients respond to the treatment. You may be eligible if you are 18 or older and have measurable disease.
- Study design
- This is a Phase 1 study, meaning it's focused on safety and dosage. It plans to enroll 12 participants.
- What's involved
- You will undergo blood and possible ascites (fluid in the abdomen) sample collection, and have CT or PET/CT scans. The T cells and other medications will be given intravenously.
- Compensation
- Not stated in the trial record.
- Follow-up
- Researchers will monitor for side effects for up to 28 days after T cell infusion and measure your response to treatment for up to 2 years.
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NCT06483048
MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~12 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:Autologous MUC1-activated T-cellsBendamustineBiospecimen CollectionComputed TomographyCyclophosphamideEchocardiography
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-limiting toxicities (DLT)
Measured over Up to 28 days after T cell infusion
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesArizona1
Study leadership
- Brenda J. Ernst, M.D. · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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)
Increase in CA-125 level to ≥ 2 x nadir (if nadir \> ULN)
If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval
PRE-REGISTRATION: Provide written informed consent
PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research
REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma
REGISTRATION: MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study
REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months
REGISTRATION: Willingness and ability to provide written informed consent
REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study
REGISTRATION: Willing to undergo leukapheresis for blood component collection
REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (performed ≤ 14 days prior to registration)
REGISTRATION: Lymphocyte count ≥ 1500/mm\^3 (performed ≤ 14 days prior to registration)
REGISTRATION: Hemoglobin ≥ 8.0 g/dL (performed ≤ 14 days prior to registration)
REGISTRATION: Platelet count ≥ 30,000/mm\^3 (performed ≤ 14 days prior to registration)
REGISTRATION: Total bilirubin ≤ 2.0 mg/dL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)
Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)
REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis \[DVT\]/pulmonary embolism \[PE\] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)
REGISTRATION: Calculated creatinine clearance ≥ 30 ml/min using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)
REGISTRATION: Baseline oxygen saturation ≥ 90% on room air
REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration
Exclusion
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
Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.
Uncontrolled concurrent illness including, but not limited to:
Inability to clear an ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Uncontrolled psychiatric problems
Inability to have a caregiver for active oversight during treatment period
Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy
Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements
Evidence of clinical immunocompromise and/or HIV positivity and currently receiving antiretroviral therapy
Patients requiring chronic supraphysiologic daily doses of steroids (\> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)
Patients receiving any other investigational agent which could be considered a treatment for the neoplasm
Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence
Diagnosis of autoimmune disease
Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded
What this trial measures
- Dose-limiting toxicities (DLT)Up to 28 days after T cell infusion
Adverse events (AEs) will be defined per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 guidelines. DLT will be defined as an AE if at least possibly related to MUC1-activated T cells.
- Maximum tolerated dose (MTD)Up to 28 days after T cell infusion
MTD is the highest dose of a drug or treatment that does not cause unacceptable side effects. MTD will be determined using the Bayesian optimal interval (BOIN) design.
- Objective response rateUp to 2 years
Tumor response will be based on combined imaging (Response Evaluation Criteria in Solid Tumors \[RECIST\] version \[v\] 1.1) and tumor markers (CA-125). Objective response rate will be defined as the proportion of patients with an overall best response of complete response (CR) or partial response (PR). Objective response rate will be summarized by descriptive summary statistics. The proportion of patients who achieve an overall as well as specific type of response will be estimated along with corresponding 95% exact binomial confidence intervals.