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Dual Target CAR-T Cells in B-cell Acute Lymphoblastic Leukemia (CAR-T)

Primary Purpose

Dual-target CAR-T Cells, B ALL, Relapse

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Dual target CAR-T cell therapy
Sponsored by
Shenzhen University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dual-target CAR-T Cells

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects must meet the following criteria to participate in this study:

    1. 14-75 years old, no gender limit;
    2. According to the 2020 World Health Organization (WHO) diagnostic criteria, it is diagnosed as relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL);
    3. ECOG behavior status score is 0-2 points;
    4. Expected survival time ≥ 3 months;
    5. No contraindications to peripheral apheresis;
    6. Flow cytometry confirms that the original cells express CD22;
    7. Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
    8. No serious heart, lung, liver or kidney disease;
    9. Ability to understand and willing to sign the informed consent form for this trial.

Exclusion Criteria:

  • Patients with any of the following cannot be included in this study:

    1. The original cells expressing CD19 and CD22 are negative;
    2. There is active infection;
    3. Abnormal liver function ( glutamic-pyruvic transaminase>1.5×ULN, glutamic oxalacetic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);
    4. People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
    5. HIV/AIDS patients;
    6. Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment;
    7. Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
    8. Known or suspected drug abuse or alcohol dependence;
    9. People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures;
    10. Those who have participated in other clinical trials within 30 days;
    11. Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom);
    12. The investigator judged that it is not suitable to participate in this trial.

Sites / Locations

  • Shenzhen University General hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Dual target CAR-T cell therapy

Outcomes

Primary Outcome Measures

Complete remission rate
No blasts in peripheral blood, no extramedullary leukemia; Three-line bone marrow hematopoietic recovery, primitive cells <5%; Peripheral blood absolute neutrophil count>1.0×10^9/L; Peripheral blood platelet count>100×10^9/L; No recurrence within 4 weeks

Secondary Outcome Measures

Overall survival rate
The proportion of surviving patients at the end of the study.

Full Information

First Posted
January 21, 2021
Last Updated
January 23, 2021
Sponsor
Shenzhen University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04723901
Brief Title
Dual Target CAR-T Cells in B-cell Acute Lymphoblastic Leukemia
Acronym
CAR-T
Official Title
Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen University General Hospital

4. Oversight

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

5. Study Description

Brief Summary
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.
Detailed Description
Prospectively evaluate the safety and effectiveness of CD19/CD22 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Strictly follow the inclusion criteria to screen eligible subjects for inclusion in clinical trials. The selected patients received CD19/CD22 dual-target CAR-T cell therapy. After the treatment is over, follow-up regularly to determine the survival status and follow-up treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dual-target CAR-T Cells, B ALL, Relapse, Refractory B Acute Lymphoblastic Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Dual target CAR-T cell therapy
Intervention Type
Biological
Intervention Name(s)
Dual target CAR-T cell therapy
Intervention Description
CD19/CD22 dual target CAR-T cell therapy
Primary Outcome Measure Information:
Title
Complete remission rate
Description
No blasts in peripheral blood, no extramedullary leukemia; Three-line bone marrow hematopoietic recovery, primitive cells <5%; Peripheral blood absolute neutrophil count>1.0×10^9/L; Peripheral blood platelet count>100×10^9/L; No recurrence within 4 weeks
Time Frame
From date of initial treatment to the end of follow up, up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival rate
Description
The proportion of surviving patients at the end of the study.
Time Frame
From admission to the end of follow up, up to 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects must meet the following criteria to participate in this study: 14-75 years old, no gender limit; According to the 2020 World Health Organization (WHO) diagnostic criteria, it is diagnosed as relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL); ECOG behavior status score is 0-2 points; Expected survival time ≥ 3 months; No contraindications to peripheral apheresis; Flow cytometry confirms that the original cells express CD22; Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression; No serious heart, lung, liver or kidney disease; Ability to understand and willing to sign the informed consent form for this trial. Exclusion Criteria: Patients with any of the following cannot be included in this study: The original cells expressing CD19 and CD22 are negative; There is active infection; Abnormal liver function ( glutamic-pyruvic transaminase>1.5×ULN, glutamic oxalacetic transaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN); People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction; HIV/AIDS patients; Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose>300mg/d; clopidogrel, dose>75mg/d) treatment; Those who received radiotherapy within 4 weeks before the start of the study (blood sampling); Known or suspected drug abuse or alcohol dependence; People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures; Those who have participated in other clinical trials within 30 days; Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom); The investigator judged that it is not suitable to participate in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
shujiao he, Dr
Phone
+86-0755-21839178
Email
he_shujiao@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yu, Dr
Organizational Affiliation
Shenzhen University General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen University General hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518055
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shujiao He, Dr
Phone
+86-0755-2183-9178
Email
he_shujiao@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no intention

Learn more about this trial

Dual Target CAR-T Cells in B-cell Acute Lymphoblastic Leukemia

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