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

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

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

Study Overview

• Status: Recruiting
• Conditions: AML
• Intervention / Treatment: Biological: CD38 CAR T-cells

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Recruiting
      • The first affiliated hospital of medical college of zhejiang university
      • Contact: Yongxian Hu, PhD; Phone Number: +8615957162012; Email: huyongxian2000@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT)	Adverse events assessed according to NCI-CTCAE v5.0 criteria	Baseline up to 28 days after CD38 CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)	Incidence of treatment-emergent adverse events [Safety and Tolerability]	Up to 90 days after CD38 CAR T-cells infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of CAR-T cells	In peripheral blood and bone marrow	From admission to the end of the follow-up, up to 2 years
Disease control rate, DCR	The percentage of patients with remission and stable disease after treatment in the total evaluable cases.	From Day 28 CD38 CAR-T infusion up to 2 years
Duration of remission, DOR	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	24 months post CD38 CAR-T cells infusion
Progression-free survival, PFS	The time from cell reinfusion to the first assessment of disease progression or death from any cause	24 months post CD38 CAR-Tcells infusion
Overall survival, OS	The time from the cell reinfusion to death due to any cause	From CD38 CAR-T infusion to death，up to 2 years

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Yake Biotechnology Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2022
• Primary Completion (Anticipated): December 5, 2024
• Study Completion (Anticipated): December 5, 2024

Study Registration Dates

• First Submitted: December 1, 2021
• First Submitted That Met QC Criteria: February 13, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 13, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: AML; CD38 CAR T-cell therapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: CD38-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No