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CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL

RecruitingEARLY Phase 1Ages 18 Years - anyAllZhejiang University
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In plain words

What the trial is, and whether it could suit you

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 1\. Gender unlimited,18\< Age; * 2\. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma * 3\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions): 1. CR not achieved after standardized chemotherapy; 2. CR achieved following the first induction, but CR duration is less than 12 months; 3. Ineffectively after first or multiple remedial treatments; 4. 2 or more relapses; * 4\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry); * 5\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments; * 6\. Relapsed or refractory B-NHL (meeting one of the following conditions): 1. No response or relapse after second-line or above chemotherapy regimens; 2. Primary drug resistance; 3. Relapse after auto-HSCT; * 7\. At least one assessable tumor lesion per Lugano 2014 criteria; * 8\. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; * 9\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%; * 10\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; * 11\. Estimated survival time ≥ 3 months; * 12\. ECOG performance status 0 to 2; * 13\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: * 1\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; * 2\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; * 3\. Pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion * 4\. Patients with HIV infection; * 5\. Active infection of hepatitis B virus or hepatitis C virus; * 6\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 7\. Other uncontrolled diseases that were not suitable for this trial; * 8\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months; * 9\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
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What it tests

  • CD19-BAFF Targeted CAR T-cells
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Where

1 site
The first affiliated hospital of medical college of zhejiang university
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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