drugset / Trial / NCT05994157

Phase 1, Open-label, Dose-escalation Trial With CD38-SADA:177 Lu-DOTA Drug Complex in Subjects With Relapsed or Refractory Non-Hodgkin Lymphoma

NCT05994157 ↗

Phase 1 Terminated 1 enrolled Y-mAbs Therapeutics
NaSingle-groupOpen-labelTreatment

Summary

Patients with non-Hodgkin Lymphoma will be treated with CD38-SADA:177Lu-DOTA complex (The IMP is a two-step radioimmunotherapy, delivered as two separate products CD38-SADA and 177Lu-DOTA) to establish optimal and safe therapeutic doses and dosing schedule of CD38-SADA, and 177Lu-DOTA.

Timeline

Start
2025-04-21
Primary completion
2025-10-15
Completion
2025-10-15

Outcome

Outcome not reported

Stopped (Enrollment): “Study is terminated by Sponsor decision due to recruitment challenges.”

Drugs

EvaluationDrugModalityDoseRoute
Subject 177Lu-DOTA Unknown — Intravenous
Subject CD38-SADA Unknown — Intravenous

Indications