eligibility_summary
Eligible: ages 16–65 with hematologic malignancy planned for CAR‑T, expected survival ≥3 months, LVEF ≥55%, ALT/AST <3× normal, creatinine <2.0 mg/dL, PT/APTT <2× normal, KPS ≥60, ECOG ≤2. Exclude: pregnant/lactating, uncontrolled infection, active HBV/HCV, HIV+, MI or severe arrhythmia in past 6 months or NYHA III–IV, any condition increasing risk or confounding per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06041815 is a prospective, observational study in patients with hematologic malignancies receiving standard-of-care CAR-T therapy. No investigational drug is tested, the study analyzes gut microbiota to correlate with CAR-T efficacy and toxicity. Intervention/drug: CAR-T is an autologous cellular gene therapy (genetically engineered T cells expressing a chimeric antigen receptor). Mechanism: MHC-independent recognition of tumor antigens on malignant hematologic cells, leading to T-cell activation, cytotoxic killing, and cytokine release. Targets: malignant blood cells expressing CAR antigens, immune pathways of T-cell activation/exhaustion and inflammation, gut microbiota–immune crosstalk potentially modulating response and adverse effects.