Poseltinib (NB02) alone for relapsed or refractory non-Hodgkin lymphoma
An Open-Label, Multicenter, Monotherapy, Dose-Escalation, Phase 1 Clinical Trial of NB02 (Posseltinib) in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma
This trial tests oral poseltinib (NB02) to see if it is safe and shows anti-lymphoma activity in adults 19–80 with relapsed or refractory follicular, mantle cell, or marginal zone lymphoma after at least two prior treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 9 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | All |
| Sponsor | NOBO Medicine Industry-sponsored |
| Drugs / interventions | poseltinib, ibrutinib, acalabrutinib, zanubrutinib, posseltinib |
| Locations | 6 sites (Hwasun and 5 other locations) |
| Trial ID | NCT07114367 on ClinicalTrials.gov |
What this trial studies
This open-label, multicenter phase 1 dose-escalation trial gives poseltinib as monotherapy to patients with relapsed or refractory non-Hodgkin lymphomas (including FL, MCL, and MZL) to characterize safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity. A standard 3+3 design will be used to identify the maximum tolerated dose (MTD) and/or the optimal biologic dose (OBD) based on safety, PK/PD, and early efficacy signals. Eligible participants are adults 19–80 with histologically confirmed disease, measurable lesions per Lugano, ECOG ≤2, and more than two prior lines of therapy; prior poseltinib exposure is excluded. The trial is conducted at several university hospitals in South Korea and will collect safety data, pharmacokinetic samples, and tumor response assessments.
Who should consider this trial
Good fit: Adults aged 19–80 with confirmed follicular, mantle cell, or marginal zone lymphoma who have relapsed or are refractory after more than two prior therapies, have measurable disease, ECOG ≤2, and can take oral medication are the intended participants.
Not a fit: Patients previously treated with poseltinib, those who cannot take oral medications, those unable to comply with study procedures, and most patients who progressed on BTK inhibitor regimens (except those who stopped BTKi due to intolerance or nonmedical reasons) are unlikely to be eligible or to benefit.
Why it matters
Potential benefit: If poseltinib proves safe and active, it could become a new oral treatment option for patients with relapsed or refractory indolent and mantle cell lymphomas.
How similar studies have performed: Other BTK inhibitors have demonstrated activity in mantle cell and marginal zone lymphoma and some benefit in relapsed indolent lymphomas, but poseltinib itself remains at an early clinical stage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 19 to 80 years. 2. Patients must voluntarily agree to participate in the study and provide written informed consent prior to any study-related procedures. 3. Patients with histologically confirmed follicular lymphoma, mantle cell lymphoma or marginal 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 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-related intolerance 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 clinical trial within 4 weeks prior to study drug administration. 6. Patients who have previously been treated with NB02 (poseltinib) or any other BTK inhibitors (e.g., ibrutinib, acalabrutinib, zanubrutinib). 7. Known HIV, HCV and HBV infection with active diseases
Where this trial is running
Hwasun and 5 other locations
- Chonnam National University Hwasun Hospital — Hwasun, South Korea (Recruiting)
- Seoul National University Bundang Hospital — Seongnam, South Korea (Recruiting)
- Catholic univ of Yeouido St Mary's Hospital — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.