eligibility_summary
Eligibility: Relapsed/refractory hematologic malignancies (CLL/SLL, selected NHL), prior/current CD19 expression or high likelihood by histology, no CNS/meningeal disease by symptoms or MRI. Exclusions: any prior CD19-directed therapy (incl. CAR-T), allogeneic HSCT <6 months, autologous HSCT <6 weeks, history/presence of GVHD.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions/mechanisms: SYNCAR-001—autologous, gene-modified CD19-directed CAR-T co-expressing an engineered orthogonal IL-2 receptor β (hoRb), eliminates CD19+ B cells via CAR signaling and can be selectively expanded/activated through hoRb. STK-009—engineered pegylated orthogonal IL-2 cytokine, biologic that binds hoRb (not native IL-2R), activating JAK/STAT5 to boost proliferation, survival, and function of SYNCAR-001 while sparing bystander cells. Cohort A also uses cyclophosphamide + fludarabine (lymphodepleting cytotoxics) to enhance CAR-T engraftment. Targets: CD19+ malignant B cells, hoIL-2/hoRb axis on infused CAR-T, IL-2R JAK/STAT pathways, reduction of endogenous lymphocytes.