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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trial of CD19/CD22 Dual Target CAR-T Cells in the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Conditions
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Dual-target CAR-T Cells, B ALL, Relapse, Refractory B Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Biological: Dual target CAR-T cell therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Dual target CAR-T cell therapy | Biological: Dual target CAR-T cell therapy<br>* CD19/CD22 dual target CAR-T cell therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From date of initial treatment to the end of follow up, up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival rate | The proportion of surviving patients at the end of the study. | From admission to the end of follow up, up to 2 years. |