Back to resultsClinical Study on Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in the Treatment of Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CLL1/+CD33 CAR-T
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML, CLL1, CD33
Eligibility Criteria
Inclusion Criteria: The patient or his/her legal guardian volunteers for the trial and signs an informed consent form; Age range 1-18 years; Acute myeloid leukemia (AML) with CLL1 and CD33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ; The main organ functions of the patients were good: (1) liver function: ALT/AST < 3 times the upper limit of normal (ULN) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine < 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (LVEF)≥40% ; The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection; ECOG score was 0-2. Exclusion Criteria: The patients had uncontrollable infectious diseases within 4 weeks before the enrollment; Active hepatitis B/C virus; HIV infection, treponema syphilis positive patients; Pathological diagnosis of primary tumors other than acute myeloid leukemia; Suffering from serious autoimmune diseases or immunodeficiency diseases; The patient is allergic to antibodies or cytokines and other macromolecular biological drugs; Pregnant or lactating women; Patients who were considered ineligible for study for other reasons.
Sites / Locations
- Fujian Provincial Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CLL1/+CD33 CAR-T
Arm Description
The target dose range for subjects was set to be 1.00~2.50x10^6/kg CAR-positive T cells.
Outcomes
Primary Outcome Measures
Changes in cytokine level after CLL1/+CD33 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.
The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.
Track CAR-T cells expansion in patients after infusion by flow cytometry
The change characteristics of chimeric antigen receptor(CAR)-T cell copy number in patients after infusion.
Track CAR-T cells expansion in patients after infusion by Real-time Quantitative Polymerase Chain Reaction（qPCR）
Secondary Outcome Measures
Event-free survival
Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes). Subjects without any of these events were counted up to the last follow-up examination date. For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death. Based on the initial event.
Overall survival
Death from any cause from the beginning of cell transfusion
Duration of Overall Response
The time from the start of cell infusion when CR or PR is first achieved to disease progression.
MRD negative rate
The rate of MRD negative subjects was determined by flow cytometry.
Full Information
NCT ID
NCT05943314
First Posted
June 9, 2023
Last Updated
July 10, 2023
Sponsor
Guangzhou Bio-gene Technology Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05943314
Brief Title
Clinical Study on Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in the Treatment of Acute Myeloid Leukemia
Official Title
Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in Refractory/Recurrent Acute Myeloid Leukemia: a Single-arm, Non-blind Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou Bio-gene Technology Co., 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
This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.
Detailed Description
The primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-CLL1 /+CD33 CAR T cells in patients with refractory/recurrent acute myeloid leukemia. A total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00~2.50x10^6/kgCAR-positive T cells.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML, CLL1, CD33
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CLL1/+CD33 CAR-T
Arm Type
Experimental
Arm Description
The target dose range for subjects was set to be 1.00~2.50x10^6/kg CAR-positive T cells.
Intervention Type
Biological
Intervention Name(s)
CLL1/+CD33 CAR-T
Intervention Description
CLL1/+CD33 CAR T is a type of CAR T cell therapy for patients with treating/relapsed acute myeloid leukemia.
Primary Outcome Measure Information:
Title
Changes in cytokine level after CLL1/+CD33 CAR-T infusion
Description
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.
Time Frame
CAR T cell infusion before and 12 months after infusion
Title
The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.
Description
Track CAR-T cells expansion in patients after infusion by flow cytometry
Time Frame
CAR T cell infusion before and 12 months after infusion
Title
The change characteristics of chimeric antigen receptor(CAR)-T cell copy number in patients after infusion.
Description
Track CAR-T cells expansion in patients after infusion by Real-time Quantitative Polymerase Chain Reaction（qPCR）
Time Frame
CAR T cell infusion before and 12 months after infusion
Secondary Outcome Measure Information:
Title
Event-free survival
Description
Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes). Subjects without any of these events were counted up to the last follow-up examination date. For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death. Based on the initial event.
Time Frame
Up to 12 months after CLL1/+CD33 CAR-T infusion
Title
Overall survival
Description
Death from any cause from the beginning of cell transfusion
Time Frame
Up to 12 months after CLL1/+CD33 CAR-T infusion
Title
Duration of Overall Response
Description
The time from the start of cell infusion when CR or PR is first achieved to disease progression.
Time Frame
Up to 12 months after CLL1/+CD33 CAR-T infusion
Title
MRD negative rate
Description
The rate of MRD negative subjects was determined by flow cytometry.
Time Frame
Up to 12 months after CLL1/+CD33 CAR-T infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient or his/her legal guardian volunteers for the trial and signs an informed consent form;
Age range 1-18 years;
Acute myeloid leukemia (AML) with CLL1 and CD33 markers (including secondary patients) was diagnosed by pathology, histology and flow cytometry, or complete hematologic remission could not be achieved after 1 course of chemotherapy for hematologic relapse after drug withdrawal ;
The main organ functions of the patients were good: (1) liver function: ALT/AST < 3 times the upper limit of normal (ULN) and bilirubin ≤34.2 μmol/l; (2) renal function: creatinine < 220 μmol/l; (3) lung function: oxygen saturation ≥95% ; (4) cardiac function: left ventricular ejection fraction (LVEF)≥40% ;
The blood flow of peripheral superficial vein was unobstructed, which could meet the demands of intravenous drip and mononuclear cell collection;
ECOG score was 0-2.
Exclusion Criteria:
The patients had uncontrollable infectious diseases within 4 weeks before the enrollment;
Active hepatitis B/C virus;
HIV infection, treponema syphilis positive patients;
Pathological diagnosis of primary tumors other than acute myeloid leukemia;
Suffering from serious autoimmune diseases or immunodeficiency diseases;
The patient is allergic to antibodies or cytokines and other macromolecular biological drugs;
Pregnant or lactating women;
Patients who were considered ineligible for study for other reasons.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Zhang, doctor
Phone
15821333007
Email
zhang-hui@scmc.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Zhang, doctor
Organizational Affiliation
Children's Hospital of Fujian Province
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Provincial Children's Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350005
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Zhang, doctor
Phone
+8615821333007
Email
zhang-hui@scmc.com.cn
12. IPD Sharing Statement
Learn more about this trial
Clinical Study on Safety and Efficacy of Anti-CLL1 /+CD33 CAR T Cells in the Treatment of Acute Myeloid Leukemia
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