Phase I/II Study of Anti-MUC1 CAR T Cells for Patients With MUC1+ Advanced Refractory Solid Tumor

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

ConditionsHepatocellular Carcinoma Non-small Cell Lung Cancer Pancreatic Carcinoma Triple-Negative Invasive Breast Carcinoma

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatocellular Carcinoma
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Phase I: 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 determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize (Mucin 1) MUC1 is safe and effective for patients with relapsed or refractory solid tumor.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

October 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+ hepatocellular carcinoma, non-small cell lung cancer, pancreatic carcinoma and triple-negative basal-like breast carcinoma.
•Hepatocellular carcinoma (HCC)
•Clinical diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients;
•Non-small cell lung cancer
•Refractory or recurrent histologically or cytologically confirmed; unresectable; non-squamous NSCLC must have been tested for epidermal growth factor receptor (EGFR) mutation and anaplastic lymphoma kinase (ALK) translocation and if positive should have received appropriate tyrosine kinase inhibitor therapy prior to enrollment;
•Pancreatic carcinoma
•Patients with histologic verification of carcinoma of the pancreas (T1-3, N0-1) who have undergone surgical resection within the past 4 - 12 weeks. Patients with R1 resections are excluded;
•Triple-negative basal-like breast carcinoma
•Patients with basal-like breast carcinoma must have confirmed triple negative (estrogen receptor negative \[ER-\]/ progesterone receptor (PR) negative \[PR-\]/ human epidermal growth factor receptor-2 (HER2) negative \[HER2-\]) .

Exclusion Criteria

•The transduction efficiency of the T cells is less than 10% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
•Patients with symptomatic central nervous system (CNS) involvement.
•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.