Immunotherapy With Chimeric Antigen Receptor-Modified T Cells for MUC1 Positive Advanced Refractory Solid Tumor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.1 site in 1 country20 target enrollmentNovember 2015

ConditionsMalignant Glioma of Brain Colorectal Carcinoma Gastric Carcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Malignant Glioma of Brain
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Adverse events attributed to the administration of the anti-MUC1 CAR-T cells
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with MUC1 positive relapsed or refractory solid tumor.

Registry

clinicaltrials.gov

Start Date

November 2015

End Date

November 2018

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects with MUC1+ malignancies in patients with no available curative treatment options who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled:
•Eligible diseases: MUC1+ malignant glioma of brain, colorectal carcinoma and gastric carcinoma.
•1a. Malignant Glioma of Brain Failure after previous standard of care initial treatment of glioblastoma multiforme; documentation by magnetic resonance imaging (MRI) of an interval increase in nodular gadolinium enhancement consistent with recurrent malignant glioma suitable for therapeutic re-resection; previous pathological diagnosis of World Health Organization (WHO) Grade IV glioma;
•1b. Colorectal Carcinoma Patients must have histologically proven adenocarcinoma primary to the colon or rectum and clinical or pathologic evidence of distant metastasis;
•1c. Gastric Carcinoma Histologically confirmed adenocarcinoma of the stomach, gastroesophageal junction or esophagus; metastatic disease or locally advanced disease not amenable to curative surgery.
•Patients 18 years of age or older, and must have a life expectancy \> 12 weeks.
•MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
•Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than
•Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
•Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR T cells.

Exclusion Criteria

•The transduction efficiency of the T cells is less than 30% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
•Pregnant or nursing women may not participate.
•Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
•Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
•History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
•Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
•Previously treatment with any gene therapy products.
•The existence of unstable or active ulcers or gastrointestinal bleeding.
•Patients with portal vein vascular invasion or extrahepatic, are excluded from this study.
•Patients with a history of organ transplantation or are waiting for organ transplantation.