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

Primary Purpose

AML

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CD38 CAR T-cells
Sponsored by
Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AML focused on measuring AML, CD38 CAR T-cell therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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:

    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.

Sites / Locations

  • The first affiliated hospital of medical college of zhejiang universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment of CD38-positive Hematological Malignancies

Arm Description

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

Outcomes

Primary Outcome Measures

Dose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events [Safety and Tolerability]

Secondary Outcome Measures

Concentration of CAR-T cells
In peripheral blood and bone marrow
Disease control rate, DCR
The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
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
Progression-free survival, PFS
The time from cell reinfusion to the first assessment of disease progression or death from any cause
Overall survival, OS
The time from the cell reinfusion to death due to any cause

Full Information

First Posted
December 1, 2021
Last Updated
February 13, 2022
Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05239689
Brief Title
Clinical Study of CD38 CAR-T Cells in the Treatment of Hematological Malignancies
Official Title
Clinical Study on the Safety and Effectiveness of CD38 CAR-T Cells in the Treatment of CD38-positive Hematological Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Anticipated)
Primary Completion Date
December 5, 2024 (Anticipated)
Study Completion Date
December 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang University
Collaborators
Yake Biotechnology Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML
Keywords
AML, CD38 CAR T-cell therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment of CD38-positive Hematological Malignancies
Arm Type
Experimental
Arm Description
Administration of CD38 CAR T-cells A dose levels of 2-8*10E6/kg are administrated for each subject.
Intervention Type
Biological
Intervention Name(s)
CD38 CAR T-cells
Intervention Description
Drug: CD38 CAR T-cells Each subject receive CD38 CAR T-cells by intravenous infusion Other Name: CD38 CAR T-cells injection
Primary Outcome Measure Information:
Title
Dose-limiting toxicity (DLT)
Description
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time Frame
Baseline up to 28 days after CD38 CAR T-cells infusion
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
Incidence of treatment-emergent adverse events [Safety and Tolerability]
Time Frame
Up to 90 days after CD38 CAR T-cells infusion
Secondary Outcome Measure Information:
Title
Concentration of CAR-T cells
Description
In peripheral blood and bone marrow
Time Frame
From admission to the end of the follow-up, up to 2 years
Title
Disease control rate, DCR
Description
The percentage of patients with remission and stable disease after treatment in the total evaluable cases.
Time Frame
From Day 28 CD38 CAR-T infusion up to 2 years
Title
Duration of remission, DOR
Description
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
Time Frame
24 months post CD38 CAR-T cells infusion
Title
Progression-free survival, PFS
Description
The time from cell reinfusion to the first assessment of disease progression or death from any cause
Time Frame
24 months post CD38 CAR-Tcells infusion
Title
Overall survival, OS
Description
The time from the cell reinfusion to death due to any cause
Time Frame
From CD38 CAR-T infusion to death，up to 2 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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: No CR was obtained after 2 courses of standard chemotherapy The first induction was CR, but the duration of CR was less than 12 months No CR was obtained after the first or multiple remedial treatment 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
He Huang, PhD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yongxian Hu, PhD
Phone
86-15957162012
Email
huyongxian2000@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
He Huang, PhD
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital of medical college of zhejiang university
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Huang, PhD
Phone
86-13605714822
Email
hehuangyu@126.com
First Name & Middle Initial & Last Name & Degree
Yongxian Hu, PhD
Phone
+8615957162012
Email
huyongxian2000@aliyun.com

12. IPD Sharing Statement

Learn more about this trial

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

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