Health Trials

MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer

ConditionsPlatinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Ovarian CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Fallopian Tube CarcinosarcomaRecurrent Female Reproductive System CarcinomaRecurrent Ovarian CarcinomaRecurrent Ovarian CarcinosarcomaRecurrent Platinum-Resistant Fallopian Tube CarcinomaRecurrent Platinum-Resistant Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Primary Peritoneal CarcinosarcomaRefractory Fallopian Tube CarcinomaRefractory Female Reproductive System CarcinomaRefractory Ovarian CarcinomaRefractory Primary Peritoneal Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Pregnant persons

Trial design

Treatments tested in this trial

  • Autologous MUC1-activated T-cells
  • Bendamustine
  • Biospecimen Collection
  • Computed Tomography
  • Cyclophosphamide
  • Echocardiography
  • Leukapheresis
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
  • Positron Emission Tomography

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov