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eligibility_summary
Inclusion: r/r CD5+ nodal PTCL or other aggressive mature T‑cell lymphomas, ≥50% CD5 on latest biopsy, ≥1 prior systemic therapy (ALCL needs prior brentuximab unless contraindicated), measurable/evaluable disease, no circulating CD5+ malignant cells. Exclusion: pregnancy, HIV, steroids/immunosuppression, immunodeficiency, recent CAR‑T/allo/auto HCT (<100 d), autoimmune/CNS disease (incl. optic neuritis), arrhythmia, uncontrolled infection/comorbidity, recent investigational/mAb/chemo/RT, prior alemtuzumab.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06420089 tests Senza5 CART5, an autologous gene-modified cellular therapy. The product is a dual population: CD5-knockout T cells plus CD5-knockout anti-CD5 CAR-T cells. Type/mechanism: CAR-T immunotherapy engineered to recognize CD5 on malignant T cells and kill via CAR-activated cytotoxicity, CD5 gene deletion prevents fratricide and may relieve CD5’s inhibitory signaling, enhancing persistence/function. Study arms: single IV infusion with or without standard lymphodepletion (fludarabine/cyclophosphamide, cytotoxic chemo to aid CAR-T expansion). Targets: CD5+ malignant T cells in nodal peripheral T-cell lymphomas, key pathways include CD5 antigen engagement, CAR signaling, T-cell activation/cytolysis. Phase I dose-escalation (BOIN) to define RP2D.