eligibility_summary
Eligibility for GEN3017: Adults ≥18 (US/Aus cHL ≥16), confirmed relapsed/refractory cHL or TCL, measurable FDG-PET–positive disease on CT/MRI, ECOG 0–1 (Karnofsky >60% if 16–<18), CD30+ tumor. cHL: R/R after ≥2–3 prior lines or refractory to 2nd line. Exclude CNS disease, prior investigational anti‑CD30 (except brentuximab), recent HSCT (auto <60d, allo <90d), chemo (<2w), major surgery (<4w), RT (curative <4w, palliative <2w), other trials (<4w/5 t½), live vaccine (<30d), or significant steroids/immunosuppressants (<14d).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
A first-in-human, open-label Phase 1/2a evaluated GEN3017 (DuoBody CD3xCD30), a subcutaneous bispecific IgG T-cell–redirecting antibody (immunotherapy). Mechanism: co-binds CD3 on endogenous T cells and CD30 (TNFRSF8) on tumor cells to form an immune synapse, activate TCR/CD3 signaling, and drive perforin/granzyme-mediated cytotoxicity and cytokine release. Indications: relapsed/refractory CD30+ classical Hodgkin lymphoma and CD30+ T-cell lymphomas. Cells/pathways targeted: CD30-expressing malignant Hodgkin Reed–Sternberg and T-cell lymphoma cells, CD3+ T lymphocytes, pathways include TCR activation and CD30-directed tumor cell elimination. Trial later terminated after portfolio re-evaluation.