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Recruiting NCT07114367

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

Phase I Interventional Non Hodgkin Lymphoma (NHL)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NB02 (Poseltinib).
Who it may be relevant to
Registry conditions: Non Hodgkin Lymphoma (NHL). Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Multicenter, Monotherapy, Dose-Escalation, Phase 1 Clinical Trial of NB02 (Posseltinib) in Patients With Relapsed/Refractory Non-Hodgkin's Lymphoma

Overview

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

Detailed 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.

Interventions

  • Drug NB02 (Poseltinib)
    Dose Level 1, Dose Level 2, Dose Level 3

Primary outcome measures

  • MTD(maximum tolerated dose) or OBD(optimal biological dose) [Time frame: Approximately 48 Months]
  • AEs [Time frame: Approximately 48 Months]
Secondary outcome measures (12)
  • Pharmacokinetic (PK) Ctrough [Time frame: Day 147]
  • Pharmacokinetic (PK) t1/2 [Time frame: Day 147]
  • Pharmacokinetic (PK) CL/F [Time frame: Day 147]
  • Pharmacokinetic (PK) Vz/F [Time frame: Day 147]
  • Pharmacokinetic (PK) Cmax [Time frame: Day 147]
  • Pharmacokinetic (PK) AUCtau [Time frame: Day 147]
  • Pharmacokinetic (PK) Tmax [Time frame: Day 147]
  • Overall response rate (ORR) [Time frame: Approximately 48 Months]
  • Duration of response (DoR) [Time frame: Approximately 48 Months]
  • Time to response (TTR) [Time frame: Approximately 48 Months]
  • Progression-free survival (PFS) [Time frame: Approximately 48 Months]
  • Overall Survival (OS) [Time frame: Approximately 48 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 6 centers
  • Chonnam National University Hwasun Hospital — Hwasun
  • Seoul National University Bundang Hospital — Seongnam
  • Catholic univ of Yeouido St Mary's Hospital — Seoul
  • Samsung Medical Center — Seoul
  • Seoul National University Hospital — Seoul
  • Ulsan University Hospital — Ulsan

Identifiers

NCT: NCT07114367 · NB02-L02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗