CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
NCT ID: NCT03896854
Last Updated: 2023-11-29
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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RECRUITING
PHASE1/PHASE2
15 participants
INTERVENTIONAL
2017-10-18
2025-12-31
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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CD19 positive relapsed or refractory acute myeloid leukemia
MICM typing confirmed CD19 positive relapsed and refractory acute myeloid leukemia
CART-19
CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10\^6 CART-19 cells/kg).
Interventions
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CART-19
CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10\^6 CART-19 cells/kg).
Eligibility Criteria
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Inclusion Criteria
* Age 6-65 years.
* Left ventricular ejection fractions≥ 0.5 by echocardiography.
* Creatinine \< 1.6 mg/dL.
* Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
* Bilirubin \<2.0 mg/dL.
* Karnofsky performance status ≥ 60
* Expected survival time ≥ 3 months (according to investigator's judgement)
Exclusion Criteria
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Class III/IV cardiovascular disability according to the New York Heart Association Classification.
* HIV infection.
* Patients with history of seizure
* Active central nervous system leukemia
6 Years
65 Years
ALL
No
Sponsors
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Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaowen Tang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Soochow University
Locations
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The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Xiaowen Tang, Ph.D.
Role: primary
Other Identifiers
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UnicarTherapy20190308
Identifier Type: -
Identifier Source: org_study_id