Clinical Study of CD38 CAR-T Cells in the Treatment of Hematological Malignancies
Study Details
Study Description
Brief Summary
Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
Condition or Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
Detailed Description
The CAR-T cell injection uses immune cells from healthy donors, and is the final product obtained after CAR genetic modification, cell expansion, culture, screening, preparation, sub-packaging, and release inspection. CD38 is highly expressed in myeloid leukemia, and it has been confirmed that the treatment of targeting CD38 has great potential in the treatment of CD38-positive hematological malignancies. The center intends to apply for a clinical trial of CD38 CAR-T cells to treat CD38-positive hematological malignancies on the basis of preliminary research.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 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. |
Biological: 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
|
Outcome Measures
Primary Outcome Measures
- Dose-limiting toxicity (DLT) [Baseline up to 28 days after CD38 CAR T-cells infusion]
Adverse events assessed according to NCI-CTCAE v5.0 criteria
- Incidence of treatment-emergent adverse events (TEAEs) [Up to 90 days after CD38 CAR T-cells infusion]
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Secondary Outcome Measures
- Concentration of CAR-T cells [From admission to the end of the follow-up, up to 2 years]
In peripheral blood and bone marrow
- Disease control rate, DCR [From Day 28 CD38 CAR-T infusion up to 2 years]
The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
- Duration of remission, DOR [24 months post CD38 CAR-T cells infusion]
The time from the first assessment of remission or partial remission of the disease to the first assessment of disease progression or death from any cause
- Progression-free survival, PFS [24 months post CD38 CAR-Tcells infusion]
The time from cell reinfusion to the first assessment of disease progression or death from any cause
- Overall survival, OS [From CD38 CAR-T infusion to death,up to 2 years]
The time from the cell reinfusion to death due to any cause
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Patients is histologically diagnosed with CD38-positive AML according to the NCCN Clinical Practice Guidelines in Oncology:Acute Myeloid Leukemia(Version 2.2021);
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- The diagnosis is consistent with r/r CD38 + AML, and includes any of the following conditions:
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No CR was obtained after 2 courses of standard chemotherapy
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The first induction was CR, but the duration of CR was less than 12 months
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No CR was obtained after the first or multiple remedial treatment
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Relapse twice or more
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- The number of blast cells in bone marrow was more than 5% (morphology) and / or > 1% (flow cytometry);
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- No active lung infection, inhaled air oxygen saturation ≥92%;
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- The estimated survival time is more than 3 months;
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- ECOG score was 0-2;
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- The patients or their legal guardians voluntarily participated in the trial and signed the informed consent.
Exclusion Criteria:
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- Patients with history of epilepsy or other central nervous system diseases;
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- Patients with prolonged QT or severe heart disease;
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- Pregnant or lactating women (the safety of this therapy for unborn children is unknown);
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- The patients with uncontrolled active infection;
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- Active hepatitis B or hepatitis C virus infection;
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- Previous application of gene therapy;
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- The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
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- Serum creatinine > 2.5mg/dl or ALT / AST > 3 times ULN or bilirubin > 2.0mg/dl;
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- Those who suffer from other uncontrolled diseases are not suitable to join the study;
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- HIV infection;
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- Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | The first affiliated hospital of medical college of zhejiang university | Hangzhou | Zhejiang | China | 310003 |
Sponsors and Collaborators
- Zhejiang University
- Yake Biotechnology Ltd.
Investigators
- Principal Investigator: He Huang, PhD, First Affiliated Hospital of Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CD38-001