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NCT04723901 | Recruiting | Dual-target CAR-T Cells


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

Shenzhen University General Hospital

Information provided by (Responsible Party):

YuLi

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.

Condition or disease

Dual-target CAR-T Cells

B ALL

Relapse

Refractory B Acute Lymphoblastic Leukemia

Intervention/treatment

Dual target CAR-T cell therapy

Phase

Phase 1

Phase 2

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.

Study Type : Interventional
Estimated Enrollment : 20 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Actual Study Start Date : October 20, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arm Intervention/treatment

Experimental: Treatment group

Dual target CAR-T cell therapy

Biological: Dual target CAR-T cell therapy

Ages Eligible for Study: 14 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

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

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

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Locations


Recruiting

China, Guangdong

Shenzhen University General hospital

Shenzhen, Guangdong, China, 518055

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