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

Zhejiang University

Status and phase

Enrolling

Early Phase 1

Conditions

Acute Lymphoblastic Leukemia,B-Cell

Non-hodgkin Lymphoma,B Cell

Treatments

Biological: CD19-BAFF Targeted CAR T-cells

Study type

Interventional

Funder types

Other

Identifiers

NCT06346912

TXB2023022

Details and patient eligibility

About

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.

Full description

In this study, 20 patients with relapsed refractory B-cell ALL and B-cell NHL were proposed to undergo CD19-BAFF CAR-T cell therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19-BAFF CAR-T cell therapy for relapsed refractory B-cell ALL and B-cell NHL; At the same time, on the basis of expanding the sample size, more safety data on CD19-BAFF CAR-T cell treatment for relapsed refractory B-cell ALL and B-cell NHL were accumulated, including rare and delayed complications.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Gender unlimited，18< Age;
1. 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
1. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
2. CR not achieved after standardized chemotherapy;
3. CR achieved following the first induction, but CR duration is less than 12 months;
4. Ineffectively after first or multiple remedial treatments;
5. 2 or more relapses;
1. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (by morphology), and/or >1% (by flow cytometry);
1. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
1. Relapsed or refractory B-NHL (meeting one of the following conditions):
2. No response or relapse after second-line or above chemotherapy regimens;
3. Primary drug resistance;
4. Relapse after auto-HSCT;
1. At least one assessable tumor lesion per Lugano 2014 criteria;
1. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
1. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
1. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
1. Estimated survival time ≥ 3 months;
1. ECOG performance status 0 to 2;
1. 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;
1. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
1. 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
1. Patients with HIV infection;
1. Active infection of hepatitis B virus or hepatitis C virus;
1. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
1. Other uncontrolled diseases that were not suitable for this trial;
1. Individuals who have received CAR-T therapy, CAR-NK therapy, or any other gene modified cell therapy product within 6 months;
1. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.