eligibility_summary
Eligible: R/R CD19+ B-cell NHL/ALL (Ph+/-) or CLL, ECOG 0-2, life >3 mo, labs: bili/AST/ALT acceptable, CrCl>50, Hgb>=7, NHL: ANC>1K, Plt>75K, ALL blasts<=30K, INR<=1.5, contraception, consent. Exclude: recent therapy/radiation/CAR-T, infection or live vaccine, unstable brain mets, recent steroids/immunosupp., autoimmune disease, major CV events/arrhythmia, QTc or LVEF<50%, recent surgery, uncontrolled DM/HTN, pregnancy, HBV/HCV/HIV, transplant, PI discretion.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CC312, an intravenous biologic immunotherapy in Phase 1 dose escalation. The protocol does not specify the exact construct, but CC312 is a CD19‑directed agent with step‑up (priming/intermediate) dosing typical of T‑cell–redirecting biologics. Mechanism of action: binds CD19 on B cells to drive immune‑mediated killing of malignant B cells (e.g., T‑cell engagement/activation and cytotoxicity), with expected on‑target depletion of normal CD19+ B cells. Cells/pathways targeted: CD19+ B‑cell malignancies (B‑NHL, B‑ALL, CLL), CD19 surface antigen on B‑cell lineage, activation of T‑cell cytotoxic pathways/immune synapse, downstream effects on B‑cell receptor co‑receptor (CD19) signaling.