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

Last updated: January 28, 2026
Sponsor: NOBO Medicine
Overall Status: Active - Recruiting

Phase

1

Condition

Lymphoma

Treatment

NB02 (Poseltinib)

Clinical Study ID

NCT07114367
NB02-L02
  • Ages 19-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 19 to 80 years.

  2. Patients must voluntarily agree to participate in the study and provide writteninformed consent prior to any study-related procedures.

  3. Patients with histologically confirmed follicular lymphoma, mantle cell lymphoma ormarginal zone lymphoma.

  4. relapsed/refractory Patients who have received more than two prior lines of therapy.

  5. Measurable disease based on Lugano classification.

  6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

  7. Adequate organ function including:

Exclusion

Exclusion Criteria:

  1. Previous treatment with NB02 (poseltinib).

  2. Patients who have experienced progression on BTKi mono or BTKi containing regimen (However, patients who discontinued treatment due to adverse-effect-relatedintolerance or for economic or social reasons remain eligible for enrollment).

  3. Unable to take oral medication.

  4. Inability to comply with study and follow-up procedures.

  5. Concurrent use of other investigational drugs or enrollment in another clinicaltrial within 4 weeks prior to study drug administration.

  6. Patients who have previously been treated with NB02 (poseltinib) or any other BTKinhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib).

  7. Known HIV, HCV and HBV infection with active diseases

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: NB02 (Poseltinib)
Phase: 1
Study Start date:
December 02, 2025
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Chonnam National University Hwasun Hospital

    Hwasun 1843841,
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam 6876792,
    South Korea

    Active - Recruiting

  • Catholic univ of Yeouido St Mary's Hospital

    Seoul 1835848,
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848,
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848,
    South Korea

    Active - Recruiting

  • Ulsan University Hospital

    Ulsan 1833747,
    South Korea

    Active - Recruiting

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