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Clinical Trials in China / NCT06346912
Recruiting Phase EARLY_PHASE1

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

NCT06346912 · tracked via the Priya Life Science China tracker
Sponsor
Zhejiang University
Phase
Phase EARLY_PHASE1
Started
2024-05-30
Last updated
2024-05-14

Condition(s) studied

Acute Lymphoblastic Leukemia,B-CellNon-hodgkin Lymphoma,B Cell

Investigational drug(s) / intervention(s)

CD19-BAFF Targeted CAR T-cells

CD19-BAFF Targeted CAR T-cells: Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The first affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06346912 on ClinicalTrials.gov ↗ ← All trials in China