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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    20
  • sponsor
    Shenzhen University General Hospital
Updated on 28 January 2021

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.

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.

Details
Condition Relapse, Burkitt's Lymphoma, Recurrent Disease, Refractory B Acute Lymphoblastic Leukemia, b all, relapsed disease, Dual-target CAR-T Cells
Treatment dual target CAR-T cell therapy
Clinical Study IdentifierNCT04723901
SponsorShenzhen University General Hospital
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

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>1.5ULN, glutamic oxalacetic transaminase>2.5ULN), abnormal renal function (serum creatinine>1.5ULN)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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