The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).
NCT ID: NCT02924753
Last Updated: 2017-12-29
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
20 participants
INTERVENTIONAL
2016-07-18
2019-12-31
Brief Summary
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Detailed Description
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Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CART-19
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
Fludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).
CART-19 cells
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
Interventions
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Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
Fludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).
CART-19 cells
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. CD19 positive B-cell acute lymphoblastic leukemia
3. Karnofsky Performance Status (KPS) \>70
4. Relapsed after allogeneic or autologous stem cell transplantation (SCT);
5. Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）
6. No serious allergic constitution
7. No other serous diseases that conflicts with the clinical program
8. No other cancer history
9. No serious mental disorder
10. Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria
2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive
3. Active hepatitis B or hepatitis C infection
4. Recent or current use of glucocorticoid or other immunosuppressor
5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases
6. Transaminase \>2.5 ULN, Bilirubin \>3 ULN，Creatinine\>1.25 ULN
7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products
8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
4 Years
70 Years
ALL
No
Sponsors
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The Beijing Pregene Science and Technology Company, Ltd.
INDUSTRY
Henan Cancer Hospital
OTHER_GOV
Responsible Party
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Yongping Song
director
Principal Investigators
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Yongping Song
Role: STUDY_DIRECTOR
Henan Cancer Hospital
Locations
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Henan Cancer Hospital
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Yongping Song
Role: primary
Other Identifiers
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HenanCH080
Identifier Type: -
Identifier Source: org_study_id