CAR-pNK Cell Immunotherapy in MUC1 Positive Relapsed or Refractory Solid Tumor
NCT ID: NCT02839954
Last Updated: 2016-12-06
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
10 participants
INTERVENTIONAL
2016-07-31
2018-07-31
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-pNK Cell immunotherapy
Enrolled patients will receive CAR-pNK cell immunotherapy with a novel specific chimeric antigen receptor targeting MUC1 antigen by infusion.
anti-MUC1 CAR-pNK cells
Interventions
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anti-MUC1 CAR-pNK cells
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Eligible diseases: MUC1+ malignant glioma of brain, colorectal carcinoma, gastric carcinoma, hepatocellular carcinoma, non-small cell lung cancer, pancreatic carcinoma and triple-negative basal-like breast carcinoma.
2. Patients 18 years of age or older, and must have a life expectancy \> 12 weeks.
3. MUC1 is expressed in malignancy tissues by immuno-histochemical (IHC).
4. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
5. Presence of measurable disease by RECIST.
6. 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-pNK cells.
7. 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.
8. Ability to give informed consent.
Exclusion Criteria
2. Pregnant or nursing women may not participate.
3. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
4. 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.
5. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
6. The existence of unstable or active ulcers or gastrointestinal bleeding.
7. Patients with a history of organ transplantation or are waiting for organ transplantation.
8. Patients need anticoagulant therapy (such as warfarin or heparin).
9. Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).
18 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 BioTherapeutics (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
References
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Del Zotto G, Marcenaro E, Vacca P, Sivori S, Pende D, Della Chiesa M, Moretta F, Ingegnere T, Mingari MC, Moretta A, Moretta L. Markers and function of human NK cells in normal and pathological conditions. Cytometry B Clin Cytom. 2017 Mar;92(2):100-114. doi: 10.1002/cyto.b.21508. Epub 2017 Feb 12.
Other Identifiers
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PG-121-001
Identifier Type: -
Identifier Source: org_study_id