Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded from Peripheral Blood in Patients with Relapsed and Resistant Ovarian Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure, Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 12
Treatments
Experimental: Treatment (MUC1-activated T cells, lymphodepletion)
Patients undergo leukapheresis over 4 hours within 14 days after registration. Patients receive cyclophosphamide IV over 60 minutes on days -5 to -3 or bendamustine IV over 10 minutes on days -5 and -4 or -4 and -3. Patients receive MUC1-activated T cells IV over 10-60 minutes on day 0 or days 0 and 21. Patients also undergo ECHO or MUGA during screening, and blood sample collection throughout the trial. In addition, patients may undergo CT, MRI, or PET/CT as clinically indicated throughout the trial. Patients may also undergo collection of ascites on study and during follow up.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov