MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer
NCT Number: NCT06483048
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Platinum-Resistant Fallopian Tube Carcinoma|Platinum-Resistant Ovarian Carcinoma|Platinum-Resistant Primary Peritoneal Carcinoma|Recurrent Fallopian Tube Carcinoma|Recurrent Fallopian Tube Carcinosarcoma|Recurrent Female Reproductive System Carcinoma|Recurrent Ovarian Carcinoma|Recurrent Ovarian Carcinosarcoma|Recurrent Platinum-Resistant Fallopian Tube Carcinoma|Recurrent Platinum-Resistant Ovarian Carcinoma|Recurrent Primary Peritoneal Carcinoma|Recurrent Primary Peritoneal Carcinosarcoma|Refractory Fallopian Tube Carcinoma|Refractory Female Reproductive System Carcinoma|Refractory Ovarian Carcinoma|Refractory Primary Peritoneal Carcinoma
Interventions: BIOLOGICAL: Autologous MUC1-activated T-cells|DRUG: Bendamustine|PROCEDURE: Biospecimen Collection|PROCEDURE: Computed Tomography|DRUG: Cyclophosphamide|PROCEDURE: Echocardiography|PROCEDURE: Leukapheresis|PROCEDURE: Magnetic Resonance Imaging|PROCEDURE: Multigated Acquisition Scan|PROCEDURE: Positron Emission Tomography
Sponsor: Mayo Clinic
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2028-09-01
Locations: Mayo Clinic in Arizona, Scottsdale, Arizona, 85259, United States

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.

Primary Outcome Measures: Dose-limiting toxicities (DLT), 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., Up to 28 days after T cell infusion|Maximum tolerated dose (MTD), 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., Up to 28 days after T cell infusion|Objective response rate, 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., Up to 2 years
Secondary Outcome Measures: Incidence of AEs, AEs will be defined per CTCAE v 5.0 guidelines. CRS and neurotoxicity will be graded using ASTCT criteria. The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns by dose level and overall. The rate of grade 3 or higher non-hematologic adverse events, and the rate of grade 4 or higher adverse event (hematologic and non-hematologic) will be computed each with corresponding 95% exact binomial confidence intervals., Up to 2 years|Toxicity profile, Toxicities will be defined per CTCAE v5 as adverse events considered to be at least possibly related to study treatment. Overall toxicity incidence will be as well as toxicity profiles by dose level will be summarized., Up to 2 years|Clinical benefit rate, Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). Clinical benefit rate will be defined as the proportion of patients with an overall best response of CR, PR or stable disease. Clinical benefit 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., Up to 2 years|Time to clinical response, Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). Will be estimated using the method of Kaplan-Meier., From registration to objective response (overall CR or PR), assessed up to 2 years|Progression-free survival, Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). The distribution of survival time will be estimated using the method of Kaplan-Meier (overall and by dose level)., From registration to disease progression or death due to any cause, assessed up to 2 years|Time to progression, Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). Time to progression will be estimated using the method of Kaplan-Meier (overall and by dose level)., From registration to disease progression, assessed up to 2 years|Overall survival, Tumor response will be based on combined imaging RECIST v 1.1 and tumor markers (CA-125). The distribution of overall survival will be estimated using the method of Kaplan-Meier (overall and by dose level)., From registration to death due to any cause, assessed up to 2 years