eligibility_summary
Adults 18–65 with CD19+ relapsed/refractory B‑cell NHL (DLBCL, FL3b/tFL, PMBCL, HGBCL) after anti‑CD20 and anthracycline, ECOG 0–1, measurable disease, adequate labs/organ function (CBC, renal, hepatic, LVEF≥45%, SpO2≥91%), contraception required. Exclude: other recent cancers, unstable systemic disease, CNS involvement, active HBV/HCV/HIV/CMV/syphilis, chronic steroids, solid organ transplant/GvHD, HSCT <2 mo, recent vaccines/trials or tx, neuro/cerebrovascular disease, hypersensitivity, life expectancy <3 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 single‑arm trial of RJMty19, an off‑the‑shelf, allogeneic biological cell therapy: lentiviral‑engineered double‑negative T cells (DNT) expressing an anti‑CD19 chimeric antigen receptor (CAR). Mechanism: CAR binding to CD19 on malignant B cells activates DNTs to mediate cytotoxic killing and deplete CD19+ tumor B cells in r/r B‑NHL. Pre‑infusion lymphodepletion is given to enhance CAR‑DNT expansion: cyclophosphamide (alkylating DNA crosslinker), fludarabine (purine analog inhibiting DNA synthesis), and etoposide (topoisomerase II inhibitor). Targets: CD19 antigen on B‑cell lymphomas, effector cells are CAR‑modified DNTs acting via CAR signaling to eliminate tumor cells. Indications include DLBCL, FL3b, transformed FL, PMBCL, and HGBCL. Design: dose escalation and expansion to assess safety, MTD, PK, and preliminary efficacy.