CD19-BAFF CAR-T cell therapy for relapsed B-cell leukemia and lymphoma

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

This study is testing a new CAR-T cell therapy for people with relapsed B-cell leukemia and lymphoma to see if it is safe and effective.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Zhejiang University (other)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06346912 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of CD19-BAFF CAR-T cell therapy in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) and B-cell non-Hodgkin lymphoma (NHL). A total of 20 patients will receive this innovative treatment, which has shown promise in previous studies. The trial aims to gather more data on the effectiveness and safety of this therapy, including the identification of rare and delayed complications. The study is designed to expand the sample size to enhance the understanding of the treatment's impact on these challenging conditions.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with relapsed or refractory CD19+ B-cell ALL or B-cell NHL.

Not a fit: Patients with B-cell malignancies that are not CD19+ or those who have not relapsed or are not refractory may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat B-cell malignancies.

How similar studies have performed: Previous studies have shown promise for CAR-T cell therapies in treating B-cell malignancies, indicating a potential for success with this novel approach.

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.

Where this trial is running

Hangzhou, Zhejiang

• The first affiliated hospital of medical college of zhejiang university — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: He Huang, MD — Zhejiang University
• Study coordinator: He Huang, MD

Conditions: Acute Lymphoblastic Leukemia,B-Cell, Non-hodgkin Lymphoma,B Cell, CD19-BAFF CAR-T