Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2015-11-30
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-T cell immunotherapy
Enrolled patients will receive CAR-T cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.
anti-MUC1 CAR-T cells
Interventions
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anti-MUC1 CAR-T cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 60.
* 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.
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
* Ability to give informed consent.
Exclusion Criteria
* 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.
* Patients need anticoagulant therapy (such as warfarin or heparin).
* Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).
* Patients treated by radiotherapy within 4 weeks prior the first apheresis.
* Patients using fludarabine or cladribine chemotherapy within two years.
18 Years
80 Years
ALL
No
Sponsors
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The First People's Hospital of Hefei
OTHER
Hefei Binhu Hospital
OTHER
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Lin Yang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Locations
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PersonGen Biomedicine (Suzhou) Co., Ltd.
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Lin Yang, Ph.D.
Role: primary
Other Identifiers
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PG-021-002
Identifier Type: -
Identifier Source: org_study_id