eligibility_summary
Eligible: adults (>=18) with first ASCT for MM (consolidation after 1st-line or 1st relapse), R/R Hodgkin, or NHL: R/R DLBCL, R/R indolent/transformed B-cell (post-2nd-line consolidation), MCL (post-1st-line consolidation), PTCL (post-1st-line consolidation or at relapse/primary refractory), life expectancy >6 mo, prior therapy allowed except CD38 Ab in past 12 mo. Exclude: recent CD38 Ab, recent investigational therapy, Isatuximab allergy, uncontrolled illness, pregnancy/lactation, HIV+.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests isatuximab (Sarclisa), an intravenous anti‑CD38 IgG1 monoclonal antibody immunotherapy, added to standard autologous stem cell transplant (ASCT) procedures versus standard procedures alone in multiple myeloma and relapsed Hodgkin/non‑Hodgkin lymphoma. Mechanism: binds CD38 on malignant and immune cells to trigger antibody‑dependent cellular cytotoxicity (ADCC), complement‑dependent cytotoxicity (CDC), and antibody‑dependent cellular phagocytosis (ADCP), induces direct apoptosis, inhibits CD38 ectoenzyme (NADase) activity to reduce adenosine‑mediated immunosuppression. Targets/pathways: CD38+ plasma cells and CD38+ lymphoma cells, depletion of CD38+ regulatory populations (Tregs, Bregs, MDSCs), modulation of graft composition and enhancement of post‑ASCT effector T‑cell recovery/function.