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

Launched by ZHEJIANG UNIVERSITY · Apr 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD19-BAFF CAR-T cell therapy for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) and B-cell non-Hodgkin lymphoma (NHL). Essentially, this therapy aims to help patients whose cancer has come back or has not responded well to other treatments. The trial is currently recruiting participants aged 18 and older who have been diagnosed with these types of blood cancers and meet specific medical criteria.

To be eligible, patients must have certain characteristics, such as having a specific type of B-cell cancer that has not responded to standard treatments or has returned multiple times. Participants can expect to receive this new therapy and be closely monitored for its safety and effectiveness. It's important to note that patients with certain health conditions or previous treatments may not qualify for this study. Overall, this trial represents a hopeful step towards improving treatment options for individuals facing these challenging cancers.

Gender

ALL

Eligibility criteria

• 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.