Clinical Study of CD38 CAR-T Cells in the Treatment of Hematological Malignancies
NCT ID: NCT05239689
Last Updated: 2022-02-15
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
EARLY_PHASE1
36 participants
INTERVENTIONAL
2022-02-28
2024-12-05
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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Treatment of CD38-positive Hematological Malignancies
Administration of CD38 CAR T-cells A dose levels of 2-8\*10E6/kg are administrated for each subject.
CD38 CAR T-cells
Drug: CD38 CAR T-cells Each subject receive CD38 CAR T-cells by intravenous infusion Other Name: CD38 CAR T-cells injection
Interventions
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CD38 CAR T-cells
Drug: CD38 CAR T-cells Each subject receive CD38 CAR T-cells by intravenous infusion Other Name: CD38 CAR T-cells injection
Eligibility Criteria
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Inclusion Criteria
* 2\. The diagnosis is consistent with r/r CD38 + AML, and includes any of the following conditions:
1. No CR was obtained after 2 courses of standard chemotherapy
2. The first induction was CR, but the duration of CR was less than 12 months
3. No CR was obtained after the first or multiple remedial treatment
4. Relapse twice or more
* 3\. The number of blast cells in bone marrow was more than 5% (morphology) and / or \> 1% (flow cytometry);
* 4\. No active lung infection, inhaled air oxygen saturation ≥92%;
* 5\. The estimated survival time is more than 3 months;
* 6\. ECOG score was 0-2;
* 7\. The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Exclusion Criteria
* 2\. Patients with prolonged QT or severe heart disease;
* 3\. Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
* 4\. The patients with uncontrolled active infection;
* 5\. Active hepatitis B or hepatitis C virus infection;
* 6\. Previous application of gene therapy;
* 7\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 8\. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
* 9\. Those who suffer from other uncontrolled diseases are not suitable to join the study;
* 10\. HIV infection;
* 11\. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Zhejiang University
OTHER
Responsible Party
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He Huang
The President of The First Affiliated Hospital, College of Medicine, Zhejiang University
Principal Investigators
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He Huang, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Zhejiang University
Locations
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The first affiliated hospital of medical college of 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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CD38-001
Identifier Type: -
Identifier Source: org_study_id
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