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

January 28, 2026 updated by: NOBO Medicine

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 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Hwasun, South Korea
        • Recruiting
        • Chonnam National University Hwasun Hospital
        • Contact:
      • Seongnam, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Catholic univ of Yeouido St Mary's Hospital
        • Contact:
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NB02 (Poseltinib)
Dose Level 1 Dose Level 2 Dose Level 3
Drug: NB02 (Poseltinib)
Dose Level 1, Dose Level 2, Dose Level 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MTD(maximum tolerated dose) or OBD(optimal biological dose)
Time Frame: Approximately 48 Months
MTD(maximum tolerated dose) or OBD(optimal biological dose)
Approximately 48 Months
AEs
Time Frame: Approximately 48 Months
AEs
Approximately 48 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) Ctrough
Time Frame: Day 147
Pharmacokinetic (PK) parameters from plasma samples
Day 147
Pharmacokinetic (PK) t1/2
Time Frame: Day 147
Pharmacokinetic (PK) parameters from plasma samples
Day 147
Pharmacokinetic (PK) CL/F
Time Frame: Day 147
Pharmacokinetic (PK) parameters from plasma samples
Day 147
Pharmacokinetic (PK) Vz/F
Time Frame: Day 147
Pharmacokinetic (PK) parameters from plasma samples
Day 147
Pharmacokinetic (PK) Cmax
Time Frame: Day 147
Pharmacokinetic (PK) parameters from plasma samples
Day 147
Pharmacokinetic (PK) AUCtau
Time Frame: Day 147
Pharmacokinetic (PK) parameters from plasma samples
Day 147
Pharmacokinetic (PK) Tmax
Time Frame: Day 147
Pharmacokinetic (PK) parameters from plasma samples
Day 147
Overall response rate (ORR)
Time Frame: Approximately 48 Months
To evaluate preliminary anti-tumor activity
Approximately 48 Months
Duration of response (DoR)
Time Frame: Approximately 48 Months
To evaluate preliminary anti-tumor activity
Approximately 48 Months
Time to response (TTR)
Time Frame: Approximately 48 Months
To evaluate preliminary anti-tumor activity
Approximately 48 Months
Progression-free survival (PFS)
Time Frame: Approximately 48 Months
To evaluate preliminary anti-tumor activity
Approximately 48 Months
Overall Survival (OS)
Time Frame: Approximately 48 Months
To evaluate preliminary anti-tumor activity
Approximately 48 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NOBO Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 3, 2025

First Submitted That Met QC Criteria

August 3, 2025

First Posted (Actual)

August 11, 2025

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NB02-L02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Hodgkin Lymphoma (NHL)

Clinical Trials on NB02 (Poseltinib)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe