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Y-mAbs Therapeutics announces FDA clearance of CD38-SADA IND application

Y-mAbs Therapeutics announced that the FDA has cleared the company’s investigational new drug, or IND, application for CD38-SADA, the company’s second program within its Self-Assembly DisAssembly Pre-targeted Radioimmunotherapy Theranostic Platform. The Phase 1 trial is a first-in-human, dose-escalation, open-label, single-arm, multi-center trial investigating the safety and tolerability of the CD38-SADA: 177Lu-DOTA Drug Complex in patients with Relapsed or Refractory non-Hodgkin Lymphoma.

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