Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL
NCT ID: NCT04740203
Last Updated: 2021-02-05
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
50 participants
INTERVENTIONAL
2021-01-31
2025-01-31
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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CAR-T therapy
Administration of CD19 and CD22 CAR T-cells
CAR-T cells targeting CD19 and CD22
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
Interventions
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CAR-T cells targeting CD19 and CD22
Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
* The immunophenotype of leukemia cells were CD19 and CD22 positive
* Ph- or Ph- like negative
* Anticipated survival time more than 12 weeks;
* Those who voluntarily participated in this trial and provided informed consent.
Exclusion Criteria
* Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
* Pregnant (or lactating) women;
* Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
* Active infection of hepatitis B virus or hepatitis C virus;
* Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
* Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
* Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
* Other uncontrolled diseases that were not suitable for this trial;
* Patients with HIV infection;
* Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
15 Years
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
Professor
Locations
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The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CD19-005
Identifier Type: -
Identifier Source: org_study_id
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