AML
Conditions
Keywords
AML, CD38 CAR T-cell therapy
Brief summary
Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
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.
Interventions
BIOLOGICALCD38 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
Sponsors
Yake Biotechnology Ltd.
Zhejiang University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 1\. Patients is histologically diagnosed with CD38-positive AML according to the NCCN Clinical Practice Guidelines in Oncology：Acute Myeloid Leukemia（Version 2.2021）; * 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
* 1\. Patients with history of epilepsy or other central nervous system diseases; * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Concentration of CAR-T cells | From admission to the end of the follow-up, up to 2 years | In peripheral blood and bone marrow |
| 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 |
| 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 |
| 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. |
Countries
China
Contacts
Primary ContactHe Huang, PhD
Backup ContactYongxian Hu, PhD
Outcome results
None listed