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

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.

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

Given IV

DRUG

Bendamustine

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood and possible ascites sample collection

PROCEDURE

Computed Tomography

Undergo CT or PET/CT

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Leukapheresis

Undergo leukapheresis

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Brenda J. Ernst, M.D. · Mayo Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-20

Primary Completion

2028-09-30

Completion

2028-09-30

FDA Drug

Yes

Countries

• United States

Study Locations