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ACTIVE NOT RECRUITING
NCT02498912
PHASE1

Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected called "modified T cells". In the screening part of this study the tumor was found to have a protein called MUC16. This protein is present on about 70% of ovarian cancers. The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard chemotherapy. We also want to find out what effects these modified T cells have on the patient and their cancer.

Official title: A Phase I Clinical Trial of Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2015-08

Completion Date

2026-08

Last Updated

2025-07-31

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

Production of Genetically-modified T cells

DRUG

Cyclophosphamide

DEVICE

IP Catheter Insertion

GENETIC

Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells

Patients who do not have sufficient CAR T cells for the assigned dose cohort will be treated in the cohort for which cells are available.

DRUG

Fludarabine

fludarabine dose 25-30 mg/m2 x 3 days

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States