Clinical Study of CD38 CAR-T Cells in the Treatment of Hematological Malignancies

Zhejiang University

Status and phase: Enrolling; Early Phase 1

Conditions: AML

Treatments: Biological: CD38 CAR T-cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05239689

CD38-001

Details and patient eligibility

About

Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies

Full 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.

Enrollment: 36 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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:

  3. No CR was obtained after 2 courses of standard chemotherapy

  4. The first induction was CR, but the duration of CR was less than 12 months

  5. No CR was obtained after the first or multiple remedial treatment

  6. 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Treatment of CD38-positive Hematological Malignancies

Experimental group

Description:

Administration of CD38 CAR T-cells A dose levels of 2-8\*10E6/kg are administrated for each subject.

Treatment:

Biological: CD38 CAR T-cells