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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

NCT02498912 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-31

No results posted yet for this study

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.

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

Sponsors & Collaborators

Principal Investigators

  • Roisin O'Cearbhaill, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02498912 on ClinicalTrials.gov