eligibility_summary
Adults ≥18 with B‑cell lymphoma planned for anti‑CD19 axi‑cel, who received ≥2 days of high‑risk broad‑spectrum antibiotics within 180 days, ECOG 0–2, consented, ANC >1000/µL at fecal enema, adequate liver/renal function, effective contraception. Exclude: recent major surgery, live vaccine <30 d, primary immunodeficiency (except IgA def), confounding illness, psych/substance issues, pregnant/nursing or positive test, IBD/IBS, or swallowing/aspiration risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Fecal microbiota transplantation (FMT, live biotherapeutic, delivered by colonoscopy plus oral capsules) added to standard chemotherapy and anti-CD19 CAR-T therapy (axicabtagene ciloleucel, autologous gene‑modified T‑cell immunotherapy) versus chemotherapy+CAR‑T alone. Mechanisms: FMT aims to reverse antibiotic‑induced gut dysbiosis, restoring microbial diversity and metabolic output to modulate systemic immunity/CAR‑T function and mitigate gut‑related GI effects. Axicabtagene ciloleucel targets CD19 on B‑cell lymphomas to trigger T‑cell activation and cytotoxic killing, conditioning chemo supports CAR‑T expansion. Targets/pathways: CD19+ malignant B cells, T‑cell effector/cytokine pathways, gut microbiome–immune–metabolite axis.