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

Early Phase 1

Recruiting

• Conditions: AML
• Interventions: Biological: CD38 CAR T-cells

• Registration Number: NCT05239689
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Study First Submitted: 2021-12-01
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-13
• Last Update Submitted: 2022-02-13
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15
• Study Start: 2022-02-28
• Primary Completion: 2024-12-05
• Study Completion: 2024-12-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment of CD38-positive Hematological Malignancies	CD38 CAR T-cells	Administration of CD38 CAR T-cells A dose levels of 2-8\*10E6/kg are administrated for each subject.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs)	Up to 90 days after CD38 CAR T-cells infusion	Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The first affiliated hospital of medical college of zhejiang university; 🇨🇳 Hangzhou, Zhejiang, China