eligibility_summary
Adults ≥18, advanced NSCLC after frontline PD‑1/PD‑L1 progression or PDAC after 1 prior, measurable disease, KRAS codon 12/13, ECOG 0–2, adequate labs, consent, provide tissue/blood, follow‑up. Exclude: pregnancy/nursing, prior anti‑CD38, recent surgery/chemo/radiation/checkpoint/live vaccine, uncontrolled illness, major cardiac/CNS, autoimmune, liver or lung disease, HIV/HBV/HCV, high‑dose steroids, bleeding, other cancer <5 y, investigational therapy, prisoners.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, recruiting: evaluates a triple immunotherapy in PDAC and anti–PD-1–refractory NSCLC—daratumumab (anti-CD38 IgG1 monoclonal antibody), TG01 KRAS-mutant peptide vaccine with QS-21 adjuvant, and nivolumab (anti-PD-1 IgG4 monoclonal antibody). Mechanisms: daratumumab binds CD38 to deplete CD38+ cells via ADCC/CDC/ADCP and may reduce adenosine-mediated immunosuppression, nivolumab blocks PD-1 to restore effector T-cell function, TG01+QS-21 primes KRAS G12/13-specific T-cell responses. Targets/pathways: CD38+ immune/tumor cells (e.g., plasma and immunosuppressive myeloid/lymphoid cells), adenosinergic pathway, PD-1/PD-L1 checkpoint on T cells, and KRAS-mutant neoantigens via antigen-presenting cell–driven T-cell priming.