RecruitingEarly Phase 1NCT06633341

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

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

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-lymphoma

\. According to the 2016 WHO classification of lymphocyte tumors, histologically confirmed CD5-positive T-cell non-Hodgkin lymphoma (T-NHL),
R/R T-NHL(meets one of the following conditions) :
Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments;
Primary drug resistance;
Relapse after autologous hematopoietic stem cell transplantation;
CD5 expression rate was \>90%;
\. According to Lugano 2014, there should be at least one evaluable tumor lesion;
\. 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;

\. History of epilepsy or other central nervous system disorders;
\. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
\. Active infection of hepatitis B virus, C virus or hepatitis E virus;
\. Active infected persons who are not cured;
\. 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-lymphoma 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.

NCT06633341