CAR-T Cell Immunotherapy in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
NCT ID: NCT02819583
Last Updated: 2016-10-25
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
2016-10-31
2019-09-30
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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PCAR-019
Enrolled patients will receive PCAR-019 with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion.
PCAR-019 (anti-CD19 CAR-T cells)
Interventions
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PCAR-019 (anti-CD19 CAR-T cells)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD19+.
2. Patients 18 years of age or older, and must have a life expectancy \> 12 weeks.
3. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
4. Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
5. 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.
6. 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.
7. 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 at the time of screening.
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. History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
6. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
7. Previously treatment with any gene therapy products.
8. The existence of unstable or active ulcers or gastrointestinal bleeding.
9. Patients need anticoagulant therapy (such as warfarin or heparin).
10. Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).
11. Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.
18 Years
ALL
No
Sponsors
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The First People's Hospital of Hefei
OTHER
Hefei Binhu Hospital
OTHER
Anhui Provincial Hospital
OTHER_GOV
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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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
Other Identifiers
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PG-019-001
Identifier Type: -
Identifier Source: org_study_id