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

Recruiting now · Phase 1

Conditions studied: Non Hodgkin Lymphoma (NHL)

In brief

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

Key facts

Study ID

NCT07114367

Run by

NOBO Medicine

People needed

9

Starts

2025-12-02

Expected to finish

2027-12-31

Last updated by the study team

2026-01-30

Who can join

Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 19 to 80 years.
• Patients must voluntarily agree to participate in the study and provide written informed consent prior to any study-related procedures.
• Patients with histologically confirmed follicular lymphoma, mantle cell lymphoma or marginal zone lymphoma.
• relapsed/refractory Patients who have received more than two prior lines of therapy.
• Measurable disease based on Lugano classification.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Adequate organ function including:

You may not qualify if…

• Previous treatment with NB02 (poseltinib).
• Patients who have experienced progression on BTKi mono or BTKi containing regimen (However, patients who discontinued treatment due to adverse-effect-related intolerance or for economic or social reasons remain eligible for enrollment).
• Unable to take oral medication.
• Inability to comply with study and follow-up procedures.
• Concurrent use of other investigational drugs or enrollment in another clinical trial within 4 weeks prior to study drug administration.
• Patients who have previously been treated with NB02 (poseltinib) or any other BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib).
• Known HIV, HCV and HBV infection with active diseases

Where it is running

• Chonnam National University Hwasun Hospital — Hwasun, South Korea (enrolling)
• Seoul National University Bundang Hospital — Seongnam, South Korea (enrolling)
• Catholic univ of Yeouido St Mary's Hospital — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Ulsan University Hospital — Ulsan, South Korea (enrolling)

Full record on ClinicalTrials.gov

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