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New treatment option for Platinum-Resistant Fallopian Tube Carcinoma
Official title MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer
ClinicalTrials.gov ID: NCT06483048
What this study is testing
What is Autologous MUC1-activated T-cells?
Autologous MUC1-activated T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for platinum-resistant fallopian tube carcinoma.
Also referred to as Autologous MUC1-activated T-lymphocytes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join 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...
- 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...
You likely can't join if
- Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally...
- Prior treatment targeting MUC1
- people 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 (people with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN)...
- 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...
- 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
What rules you out
- 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...
- Prior treatment targeting MUC1
- people 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.