eligibility_summary
Adults (≥18) at NYU Langone. Cohort A: listed for lung or lung-involving multi-organ transplant requiring peri-transplant desensitization, pre-Tx DSA ≥5000 MFI. Cohort B: post-lung transplant with allograft dysfunction plus AMR evidence (suggestive histopathology, C4d+, or DSA ≥2000 MFI). Exclude prior rituximab/tocilizumab ≤6 mo, isatuximab hypersensitivity, pregnancy/lactation, malignancy, active infection, HBV, HIV. Consent required.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Pilot, early-phase interventional study (withdrawn before enrollment) adding isatuximab to standard desensitization/AMR therapy in lung transplant recipients. Isatuximab (SARCLISA) is an anti-CD38 IgG1 monoclonal antibody that depletes CD38+ plasma cells/plasmablasts via ADCC/CDC/apoptosis and inhibits CD38 ectoenzyme activity, reducing donor-specific antibody (DSA) production. Standard therapy includes plasmapheresis (removes circulating antibodies), IVIG (immunomodulatory, neutralizes pathogenic antibodies, modulates Fc-receptor/complement), and rituximab (anti-CD20 mAb depleting B cells). Targets/pathways: long-lived antibody-secreting plasma cells in bone marrow, CD38 and CD20 B-cell compartments, humoral alloimmunity driving AMR, and downstream complement activation (C4d). Bone marrow biopsy assesses plasma-cell elimination, DSA and flow crossmatch monitored.