eligibility_summary
Incl: ≥18, CD19+ R/R DLBCL or related (tFL, HGBL, PMBL, FL3b) after ≥2 lines or post‑auto‑HSCT, measurable, ECOG 0–1, labs ok, cardio‑pulm ok, CNS‑neg. Excl: prior allo‑HSCT/organ tx, active infection incl. HBV/HCV/HIV/CMV/EBV or syphilis, CNS disease/lymphoma, prior anti‑CD19/CAR‑T, severe autoimmune, recent thrombosis, other recent cancer, recent cytotoxic/immunosuppressive Rx or growth factors (per windows), pregnancy/lactation or no contraception, recent trials, live vaccines <3 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Phase I, dose-escalation/expansion in relapsed/refractory CD19+ DLBCL. Intervention: RC19D2 (dinorencel) cell injection—an autologous, genetically modified anti‑CD19 CAR‑T cell therapy (biological/cellular immunotherapy). Mechanism: Patient T cells are engineered to express a chimeric antigen receptor that binds CD19 on B cells, inducing antigen-dependent T‑cell activation, proliferation, and cytotoxic killing (perforin/granzyme) with expected on‑target B‑cell aplasia and cytokine release. Targets: CD19-expressing malignant (and normal) B cells, activates T‑cell effector pathways via CAR signaling (bypassing native TCR). Primary aim: assess safety/tolerability across four dose levels.