Poseltinib (NB02) alone for relapsed or refractory non-Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ALA-101 in CD19+ blood cancers

  A small early-phase test to see if ALA-101, an off-the-shelf CAR-iNKT cell therapy, is safe and potentially effective in adults with CD19-positive NHL or leukemia.

  Recruiting Phase 1 Arovella Therapeutics Ltd · Sydney, New South Wales and 4 other locations · NCT07518329

• Radiation, Vancomycin, and CAR-T for B-Cell Lymphoma

  This trial tests if giving radiation and the antibiotic vancomycin before CAR-T cell therapy is feasible for adults with large B-cell lymphomas.

  Recruiting Phase 1 Abramson Cancer Center at Penn Medicine · Philadelphia, Pennsylvania · NCT07478848

• LV009 infusion for relapsed/refractory CD19-positive blood cancers

  This early-phase study will test whether LV009 infusion is safe and how it behaves in adults with relapsed or refractory CD19-positive blood cancers such as NHL or ALL.

  Recruiting Early Phase 1 PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Hefei, Anhui · NCT07312630

• OriV508 injection for relapsed or refractory multiple myeloma and aggressive B‑cell lymphoma

  We will try OriV508, an in‑body lentiviral therapy carrying a BCMA/CD19 dual‑target CAR, in adults whose multiple myeloma or aggressive B‑cell lymphoma has returned or not responded to prior treatments.

  Recruiting Early Phase 1 Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07101705

• Combination therapy for relapsed or refractory primary CNS lymphoma

  This study is testing a new combination of medications to see if it can help people with relapsed or hard-to-treat primary central nervous system lymphoma feel better.

  Recruiting Phase 2 NOBO Medicine · Busan and 9 other locations · NCT06737250

• CAR-T cell therapy for patients with relapsed B cell cancers

  This study is testing a new CAR-T cell therapy for adults with relapsed B cell cancers to see how well it works and if different manufacturing methods make a difference in treatment outcomes.

  Recruiting Phase 1/2 Medical College of Wisconsin · Milwaukee, Wisconsin · NCT04186520

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.