Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)
NCT ID: NCT04884984
Last Updated: 2021-05-13
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
2017-07-01
2024-12-31
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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CLL1 positive relapsed or refractory acute myeloid leukemia
anti-CLL1 CART
Split intravenous infusion of anti-CLL1 CAR T cells \[dose escalating infusion of (5-20)x10\^6 anti-CLL1 CAR T cells/kg\].
Interventions
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anti-CLL1 CART
Split intravenous infusion of anti-CLL1 CAR T cells \[dose escalating infusion of (5-20)x10\^6 anti-CLL1 CAR T cells/kg\].
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
* Total bilirubin \<2.0 mg/dL
* Karnofsky performance status ≥ 60
* Expected survival time ≥ 3 months (according to investigator's judgement)
Exclusion Criteria
* Uncontrolled active infection
* Class III/IV cardiovascular disability according to the New York Heart Association Classification
* Active hepatitis B or hepatitis C infection
* Patients with HIV infection
* Patients with history of seizure
* Active central nervous system leukemia
6 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Soochow University
OTHER
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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Other Identifiers
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UnicarTherapy2021001
Identifier Type: -
Identifier Source: org_study_id
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