A Clinical Study on the Safety and Effectiveness of Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

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 targeting CD5 CAR-T Cells in the treatment of r/r CD5+ T-ALL

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 1\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;

• 2\. Consistent with r/r CD5+T-ALL diagnosis, including any of the following conditions:

‣ No CR after standard chemotherapy;

⁃ The first induction reaches CR, but CR ≤ 12 months;

⁃ Patients with r/r CD5+T-ALL have not responded to the first or multiple remedial treatments;

• c.Multiple recurrences.

• 3\. CD5 expression rate was \>90%;

• 4\. Number of blasts in the bone marrow (protolychic + larvae) \>5% (morphology) and/or \>1% (flow cytometry);

• 5\. Total bilirubin ≤51 (mol/L), Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 3 times the upper limit of the normal range, creatinine ≤176.8 (mol/L);

• 6\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;

• 7.Refers to the pulse oxygen saturation 92% or higher oxygen (state);

• 8.Estimated life expectancy of minimum of 12 weeks;

• 9.ECOG 0-2;

• 10.Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;

• 11\. Those who voluntarily participated in this trial and provided 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
057187233772
Backup
Yongxian Hu, MD
huyongxian2000@aliyun.com
057187233772
Time Frame
Start Date: 2024-10-20
Estimated Completion Date: 2027-10-20
Participants
Target number of participants: 30
Treatments
Experimental: Administration of CD5+ T-ALL 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