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

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.

Inclusion criteria

• 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:

Exclusion criteria

• 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