NCT07114367

NB02(POSELTINIB) Monotherapy in R/R Non-Hodgkin's Lymphoma

An Open-Label, Multicenter, Monotherapy, Dose-Escalation, Phase 1 Clinical Trial of NB02 (Posseltinib) in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: NOBO Medicine · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-label, multicenter, monotherapy, dose-escalation, phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of NB02 (posseltinib) in patients with relapsed/refractory NHL including FL, MCL and MZL

Detailed description

The study will conduct dose-finding. The dose-finding will be set as 3+3 design to seek candidates for optimal doses. Patients will receive study drugs to determine the MTD and/or OBD. In this study, OBD is defined as the most reasonable dose considering the benefit/risk ratio from available non-clinical and clinical data. The OBD will be determined based on available safety, PK/PD, and preliminary efficacy data, with a focus on identifying the dose that optimally balances clinical activity and tolerability.

Conditions

• Non Hodgkin Lymphoma (NHL)

Interventions

Type	Name	Description
DRUG	NB02 (Poseltinib)	Dose Level 1, Dose Level 2, Dose Level 3

Timeline

• Start date: 2025-12-02
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-08-11
• Last updated: 2026-01-30

Locations

6 sites across 1 country: South Korea