Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer
Mayo Clinic
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.
Description
PRIMARY OBJECTIVE: I. To determine the maximum tolerated dose (MTD) of autologous MUC1-activated T-cells (in-house, manufactured MUC1-activated T cells) in patients with relapsed/refractory MUC1-expressing ovarian cancer. SECONDARY OBJECTIVES: I. Obtain preliminary efficacy associated with MUC1-targeting peripheral blood mononuclear cells (PBMC)-derived T cells in conjunction with cyclophosphamide (CTX) in MUC1-expressing ovarian cancer patients as measured by objective response rate (best overall response of either partial response \[PR\] or complete response \[CR\]), duration of response,…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 ovari…
Interventions
- BiologicalAutologous MUC1-activated T-cells
Given IV
- DrugBendamustine
Given IV
- ProcedureBiospecimen Collection
Undergo blood and possible ascites sample collection
- ProcedureComputed Tomography
Undergo CT or PET/CT
- DrugCyclophosphamide
Given IV
- ProcedureEchocardiography
Undergo ECHO
- ProcedureLeukapheresis
Undergo leukapheresis
Location
- Mayo Clinic in ArizonaScottsdale, Arizona