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

NCT ID: NCT07114367

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

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.

Conditions

Non Hodgkin Lymphoma (NHL)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NB02 (Poseltinib)

Dose Level 1 Dose Level 2 Dose Level 3

Group Type: EXPERIMENTAL

NB02 (Poseltinib)

Intervention Type: DRUG

Dose Level 1, Dose Level 2, Dose Level 3

Interventions

NB02 (Poseltinib)

Dose Level 1, Dose Level 2, Dose Level 3

Intervention Type: DRUG

Eligibility Criteria

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 (e.g., at least one lesion ≥ 1.5 cm on CT or PET-CT).

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NOBO Medicine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NB02-L02

Identifier Type: -

Identifier Source: org_study_id