CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia
NCT ID: NCT04351022
Last Updated: 2020-04-24
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
2023-12-31
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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CD38 positive relapsed or refractory acute myeloid leukemia
CART-38
Split intravenous infusion of CART-38 cells \[dose escalating infusion of (5-20)x10\^6 CART-38 cells/kg\].
Interventions
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CART-38
Split intravenous infusion of CART-38 cells \[dose escalating infusion of (5-20)x10\^6 CART-38 cells/kg\].
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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References
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Cui Q, Liang P, Dai H, Cui W, Cai M, Ding Z, Ma Q, Yin J, Li Z, Liu S, Kang L, Yao L, Cen J, Shen H, Zhu M, Yu L, Wu D, Tang X. Case report: CD38-directed CAR-T cell therapy: A novel immunotherapy targeting CD38- positive blasts overcomes TKI and chemotherapy resistance of myeloid chronic myeloid leukemia in blastic phase. Front Immunol. 2022 Nov 29;13:1012981. doi: 10.3389/fimmu.2022.1012981. eCollection 2022.
Cui Q, Qian C, Xu N, Kang L, Dai H, Cui W, Song B, Yin J, Li Z, Zhu X, Qu C, Liu T, Shen W, Zhu M, Yu L, Wu D, Tang X. CD38-directed CAR-T cell therapy: a novel immunotherapy strategy for relapsed acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation. J Hematol Oncol. 2021 May 25;14(1):82. doi: 10.1186/s13045-021-01092-4.
Other Identifiers
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UnicarTherapy2020001
Identifier Type: -
Identifier Source: org_study_id
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