eligibility_summary
Inclusion: R/R LBCL, ≥1 measurable lesion, adequate organ/bone marrow. Exclusion: other cancer unless disease‑free ≥2y, Richter transformation, allo‑SCT or auto‑SCT <6 wks, CD19 Ab unless prior response + CD19+ by IHC, bendamustine <6 mo, prior CAR/gene‑modified cells, uncontrolled infection or IV antimicrobials, HIV/active HBV/HCV, CNS disorder (CNS lymphoma ok), cardiac disease <12 mo, primary immunodeficiency, autoimmune with organ injury or systemic therapy ≤2y, DVT/PE <3 mo, pregnant/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
- KITE-197: autologous chimeric antigen receptor (CAR) T-cell therapy (genetically modified cell therapy), given as a single IV infusion after lymphodepletion. Mechanism: patient T cells are engineered to express a CAR that binds a B‑cell surface antigen (antigen not specified in the record), triggering T-cell activation (CD3ζ/co-stimulation), cytotoxicity, and elimination of malignant B cells, on-target depletion of normal B cells is expected. - Cyclophosphamide: alkylating chemotherapy used for lymphodepletion, crosslinks DNA, reducing host lymphocytes to improve CAR T expansion. - Fludarabine: purine analog antimetabolite used for lymphodepletion, impairs DNA synthesis and lymphocytes, promoting CAR T engraftment. Targets: malignant large B-cell lymphoma cells, T-cell effector pathways, host lymphocyte compartment (for conditioning).