eligibility_summary
Adults (≥18) with CD38+ T-ALL. Cohort 1: relapsed/refractory (≥5% marrow blasts after ≥3 cycles, includes early/late/post-SCT relapse, refractory or ≥2nd relapse) with material for MRD. Cohort 2: in CR with quantifiable MRD ≥10^-4 after ≥3 cycles. ECOG 0–2/0–1, adequate counts, liver/renal, consent, contraception, GMALL registry. Exclude active extramedullary disease, recent chemo/immuno/investigational tx, Nelarabine candidates, recent SCT/GvHD, infections, HIV/HBV/HCV, other active cancers, allergies, pregnancy, live vaccines.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase II trial in adults with CD38+ T-ALL (relapsed/refractory or MRD+). Interventions: Isatuximab (anti-CD38 IgG1 monoclonal antibody), in Cohort 1 combined with standard chemotherapy plus bortezomib (proteasome inhibitor), with optional isatuximab maintenance, in Cohort 2, isatuximab monotherapy for MRD+ disease. Mechanisms: Isatuximab binds CD38 on leukemic T cells, inducing ADCC/CDC/ADCP and direct apoptosis, and inhibits CD38 ectoenzyme (NADase/cyclase) activity, reducing adenosine-mediated immunosuppression. Bortezomib inhibits the 26S proteasome, disrupting protein homeostasis and NF-κB signaling to trigger apoptosis. Targets: CD38+ T-ALL blasts, Fc-mediated immune cytotoxicity, CD38–adenosine axis, proteasome/NF-κB pathway. Goal: achieve remission in R/R and eradicate MRD.