RecruitingEarly Phase 1NCT06633354

Targeting CD5 CAR-T Cells in the Treatment of r/r CD5+ T-ALL

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

Sponsor

Zhejiang University

Enrollment

30 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

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

\. According to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020. v1), patients diagnosed as CD5+T-ALL;
\. 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.
\. CD5 expression rate was \>90%;
\. Number of blasts in the bone marrow (protolychic + larvae) \>5% (morphology) and/or \>1% (flow cytometry);
\. 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);
\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
Refers to the pulse oxygen saturation 92% or higher oxygen (state);
Estimated life expectancy of minimum of 12 weeks;
ECOG 0-2;
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;
\. Those who voluntarily participated in this trial and provided informed consent;

Patients with the history of epilepsy or other CNS disease;
\. Patients with prolonged QT interval time or severe heart disease;
\. Active infection of hepatitis B virus, C virus or hepatitis E virus;
\. Active infection with no cure;
\. Before using any gene therapy products;
\. Received anti-tumor therapy before infusion, should meet the following any one should be ruled out:
treated with systemic corticosteroids therapy within 72 hours (except glucocorticoid physiological replacement therapy, such as prednisone \< 10 mg/d or an equivalent dose of the drug);
received within 72 hours of small molecule targeted therapy;
weeks received systemic chemotherapy except (pretreatment);
four weeks received radiotherapy;
\. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
\. Any unsuitable to participate in this trial judged by the investigator;
\. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.

BIOLOGICALCD5 CAR T-cells

Each subject receive CD5+ T-ALL Targeted CAR T-cells by intravenous infusion

The first affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT06633354