A Clinical Study on the Safety and Effectiveness of Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

A Clinical Study on the Safety and Effectiveness of donor derived CD19 CAR-T Cells in the treatment of R/R B-cell acute lymphoblastic leukemia

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age ≥18 years old, gender unlimited;

• 2\. Abnormal B cell immunotyping was CD19 positive;

• 3\. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping;

• 4\. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions:

‣ No CR was obtained after standard chemotherapy;

⁃ CR was induced for the first time, but the duration of CR was less than 12 months;

⁃ R/R B-ALL that does not work after the first or more remedial treatments;

⁃ Two or more relapses;

• 5\. The researchers believed that the patient had been adequately treated, such as auto-HSCT, auto-CART could not be prepared or preparation failed. Autologous CAR-T preparation failure was defined as including too few autologous lymphocytes (\<1×109) or insufficient expansion during preparation or failure to meet the release criteria;

• 6\. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L);

• 7\. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin ≧60g/L;

• 8\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%;

• 9\. The estimated survival is more than 3 months;

• 10\. ECOG score 0-2;

• 11\. Women and men who are fertile must consent to the use of appropriate contraception before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known, with unknown risks);

• 12\. Subjects who are willing to participate in the study are able to understand and have the ability to sign 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
0571-87233772
Backup
Yongxian Hu, MD
huyongxian2000@aliyun.com
0571-87233772
Time Frame
Start Date: 2025-01-31
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 15
Treatments
Experimental: Administration of CD19 B-cell Acute Lymphoblastic Leukemia 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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