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Recruiting EARLY_Phase 1 NCT06633341

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

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Trial Parameters

Condition T-lymphoblastic Lymphoma
Sponsor Zhejiang University
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 30
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2024-10-20
Completion 2027-10-20
Interventions
CD5 CAR T-cells

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Brief Summary

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

Eligibility Criteria

Inclusion Criteria: * 1\. 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) : 1. Subjects did not go into remission or relapse after receiving second-line or more chemotherapy regiments; 2. Primary drug resistance; 3. Relapse after autologous hematopoietic stem cell transplantation; * 2.CD5 expression rate was \>90%; * 3\. According to Lugano 2014, there should be at least one evaluable tumor lesion; * 4\. 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); * 5\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%; * 6\. Refers to the pulse oxygen saturation 92% or higher oxygen (state); * 7\. Estimated life expectancy of minimum of 12 weeks; * 8\. ECOG 0-2; * 9\. Pregnant/lactating women, or male or female patients who

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