NCT07114367

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
20mo left

Started Dec 2025

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

July 3, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

July 3, 2025

Last Update Submit

January 28, 2026

Conditions

Non Hodgkin Lymphoma (NHL)

Keywords

RelapsedRefractoryLymphomaNHLFLMCLMZL

Outcome Measures

Primary Outcomes (2)

  • MTD(maximum tolerated dose) or OBD(optimal biological dose)

    MTD(maximum tolerated dose) or OBD(optimal biological dose)

    Approximately 48 Months

  • AEs

    AEs

    Approximately 48 Months

Secondary Outcomes (12)

  • Pharmacokinetic (PK) Ctrough

    Day 147

  • Pharmacokinetic (PK) t1/2

    Day 147

  • Pharmacokinetic (PK) CL/F

    Day 147

  • Pharmacokinetic (PK) Vz/F

    Day 147

  • Pharmacokinetic (PK) Cmax

    Day 147

  • +7 more secondary outcomes

Study Arms (1)

NB02 (Poseltinib)

EXPERIMENTAL

Dose Level 1 Dose Level 2 Dose Level 3

Drug: NB02 (Poseltinib)

Interventions

NB02 (Poseltinib)DRUG

Dose Level 1, Dose Level 2, Dose Level 3

NB02 (Poseltinib)

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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

MeSH Terms

Conditions

Lymphoma, Non-HodgkinRecurrenceLymphoma

Interventions

poseltinib

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2025

First Posted

August 11, 2025

Study Start

December 2, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

KR(6)