NB02(POSELTINIB) Monotherapy in R/R Non-Hodgkin's Lymphoma | NCT07114367

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

NCT07114367

Sponsor

NOBO Medicine

Status

Recruiting

Last Update Posted

Jan 30, 2026Actual

Enrollment

9Estimated

Phase

Phase 1

Conditions

Non Hodgkin Lymphoma (NHL)

Interventions

NB02 (Poseltinib)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2, 2025Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jul 3, 2025

First Submission Date that Met QC Criteria

Aug 3, 2025

First Posted Date

Aug 11, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2026

Last Update Posted Date

Jan 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NB02 (Poseltinib)	Experimental	Dose Level 1 Dose Level 2 Dose Level 3	Drug: NB02 (Poseltinib)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NB02 (Poseltinib)	Drug	Dose Level 1, Dose Level 2, Dose Level 3	NB02 (Poseltinib)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pharmacokinetic (PK) Ctrough	Pharmacokinetic (PK) parameters from plasma samples	Day 147
Pharmacokinetic (PK) t1/2	Pharmacokinetic (PK) parameters from plasma samples

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Chonnam National University Hwasun Hospital	Recruiting	Hwasun			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D008228	Lymphoma, Non-Hodgkin
D012008	Recurrence
D008223	Lymphoma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases

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Browse Branches

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