RecruitingEarly Phase 1NCT06346912

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

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

Sponsor

Zhejiang University

Enrollment

20 participants

Start Date

May 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 18 Years

Inclusion Criteria20

\. Gender unlimited，18\< Age;
\. 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
\. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
CR not achieved after standardized chemotherapy;
CR achieved following the first induction, but CR duration is less than 12 months;
Ineffectively after first or multiple remedial treatments;
or more relapses;
\. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is \>5% (by morphology), and/or \>1% (by flow cytometry);
\. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
\. Relapsed or refractory B-NHL (meeting one of the following conditions):
No response or relapse after second-line or above chemotherapy regimens;
Primary drug resistance;
Relapse after auto-HSCT;
\. At least one assessable tumor lesion per Lugano 2014 criteria;
\. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
\. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
\. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
\. Estimated survival time ≥ 3 months;
\. ECOG performance status 0 to 2;
\. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria9

\. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
\. 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
\. Patients with HIV infection;
\. Active infection of hepatitis B virus or hepatitis C virus;
\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
\. Other uncontrolled diseases that were not suitable for this trial;
\. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;
\. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.