eligibility_summary
Eligibility: 18–75, CD19+ B‑cell NHL (DLBCL, PMBCL, TFL, HGBCL, FL, MCL, MZL), relapsed ≥2 lines or refractory (aggressive) with required prior therapy (MCL: anti‑CD20 + anthracycline/bendamustine + BTKi, others: anti‑CD20 + anthracycline), ECOG 0–2, measurable disease, biopsy/tissue, adequate organs/blood, contraception/consent. Exclude CNS disease, pregnancy, prior allo/organ Tx, prior CD19/CAR‑T, recent RT/IO/trial, immunodeficiency/autoimmune on IS, uncontrolled infection/cardiac, effusions, recent stroke/surgery, allergies, or other safety concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: 1) Allogeneic TRAC locus–inserted CD19-targeting STAR T cells (engineered T‑cell/cellular gene therapy). Mechanism: healthy-donor T cells are CRISPR-edited to knock out TRAC (removes endogenous TCR to lower GvHD), HLA‑A/B (reduces host rejection), CIITA (limits MHC‑II), and PD‑1 (abrogates inhibitory checkpoint). An anti‑CD19 STAR receptor is integrated into the TRAC locus via AAV to redirect activation and cytotoxicity against CD19+ cells and improve resistance to immunosuppression. 2) Fludarabine (purine analog antimetabolite) and 3) Cyclophosphamide (alkylating agent) are given as lymphodepleting chemotherapy to promote STAR T engraftment/expansion. Cells/pathways targeted: malignant CD19+ B cells, TCR signaling (replaced by STAR), PD‑1/PD‑L1 checkpoint, antigen presentation (HLA‑A/B, CIITA/MHC‑II), and host‑versus‑graft/GvHD pathways.