Anti-FLT3 CAR T-cell Therapy in FLT3 Positive Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT05023707
Last Updated: 2021-12-30
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
5 participants
INTERVENTIONAL
2021-12-31
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-T infusion
FLT3 positive relapsed or refractory acute myeloid leukemia
anti-FLT3 CAR-T
Single intravenous infusion of anti-FLT3 CAR-T cells
Interventions
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anti-FLT3 CAR-T
Single intravenous infusion of anti-FLT3 CAR-T cells
Eligibility Criteria
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Inclusion Criteria
* Age 16-65 years.
* Left ventricular ejection fractions ≥ 0.5 by echocardiography
* Creatinine \< 1.5x upper limit of normal.
* Aspartate aminotransferase/aspartate aminotransferase ≤ 2.5x upper limit of normal
* Total bilirubin ≤ 1.5x upper limit of normal
* Karnofsky performance status ≥ 60
* Expected survival time ≥ 3 months (according to investigator's judgement)
Exclusion Criteria
* Uncontrolled active infection
* Grade 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 a history of seizure
* Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)
16 Years
65 Years
ALL
No
Sponsors
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The First Affiliated Hospital with Nanjing Medical University
OTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
The Second People's Hospital of Huai'an
OTHER
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
INDUSTRY
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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Xiaowen Tang, Ph.D
Role: primary
Other Identifiers
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2021136
Identifier Type: -
Identifier Source: org_study_id