eligibility_summary
WHO 2016 CD5+ T-NHL (CD5>90%), R/R after >=2nd-line, primary refractory, or post-auto-HSCT relapse, measurable lesion (Lugano 2014), adequate organs (TBil <=51, ALT/AST <=3x ULN, Cr <=176.8), LVEF >=50%, SpO2 >=92%, ECOG 0-2, life >=12 wks, not pregnant/lactating, contraception required. Exclude: CNS disease, QT prolongation/serious cardiac disease, active HBV/HCV/HEV/other infection, prior gene therapy, recent therapy (steroids/small molecules <=72h, chemo <=2w, RT <=4w), CD3/CD28 prolif <5x, investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD5 CAR T-cells—gene-modified cellular immunotherapy (biological) delivered by IV infusion, Early Phase 1, single-arm 3+3 dose escalation. Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor that specifically binds CD5 on tumor cells. CAR engagement triggers T-cell activation and expansion with MHC-independent signaling, leading to immune-mediated killing via cytokine release and perforin/granzyme cytotoxicity. Cells/pathways targeted: CD5 antigen on malignant T cells in relapsed/refractory CD5+ T-lymphoma (including T-lymphoblastic lymphoma). On-target effects may also impact normal CD5+ T cells.