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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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):

‣ 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;

⁃ 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):

‣ No response or relapse after second-line or above chemotherapy regimens;

⁃ Primary drug resistance;

⁃ 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.

Locations
Other Locations
China
The first affiliated hospital of medical college of zhejiang university
RECRUITING
Hangzhou
Contact Information
Primary
He Huang, MD
hehuangyu@126.com
86-13605714822
Backup
Yongxian Hu, MD
huyongxian2000@aliyun.com
86-15957162012
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 20
Treatments
Experimental: Administration of CD19-BAFF Targeted CAR T-cells
Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Sponsors
Collaborators: Yake Biotechnology Ltd.
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov

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