Non Hodgkin Lymphoma (NHL)Phase 1POTENTIAL-MNCT07114367
NB02(POSELTINIB) Monotherapy in R/R Non-Hodgkin's Lymphoma
A Phase 1 study testing NB02 (Poseltinib) in people with Non Hodgkin Lymphoma (NHL), run by NOBO Medicine at 6 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Non Hodgkin Lymphoma (NHL)
- What is being tested?
- NB02 (Poseltinib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 2 Dec 2025to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun
Deok-Hwan Yang, 82-61-379-7636, drydh1685@hotmail.com
- Recruiting
Seoul National University Bundang Hospital
Seongnam
Jeong-Ok Lee, 82-31-787-7055, deafkeller@snubh.org
- Recruiting
Catholic univ of Yeouido St Mary's Hospital
Seoul
Young Woo Jeon, 82-2-3779-1049, native47@catholic.ac.kr
- Recruiting
Samsung Medical Center
Seoul
Won Seog Kim, 82-2-2148-7390, wonseog.kim@samsung.com
- Recruiting
Seoul National University Hospital
Seoul
Jamin Byun, 82-2-2072-4850, jaminbyun@snu.ac.kr
- Recruiting
Ulsan University Hospital
Ulsan
Jae Cheol Jo, 82-52-250-7048, jcjo@uuh.ulsan.kr
About this study
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
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
Read the 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)
- Being tested
- NB02 (Poseltinib)
- Keywords
- Relapsed, Refractory, Lymphoma, NHL, FL, MCL, MZL
- Medical subject headings
- Lymphoma, Non-Hodgkin, Recurrence, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB02 (Poseltinib)Drug
Dose Level 1, Dose Level 2, Dose Level 3
| Study group | Role | What they receive |
|---|---|---|
| NB02 (Poseltinib) | Experimental | Dose Level 1 Dose Level 2 Dose Level 3 Receives: Drug: NB02 (Poseltinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD(maximum tolerated dose) or OBD(optimal biological dose)
MTD(maximum tolerated dose) or OBD(optimal biological dose)
Measured: Approximately 48 Months
AEs
AEs
Measured: Approximately 48 Months
Secondary outcomes (12)
Pharmacokinetic (PK) Ctrough
Pharmacokinetic (PK) parameters from plasma samples
Measured: Day 147
Pharmacokinetic (PK) t1/2
Pharmacokinetic (PK) parameters from plasma samples
Measured: Day 147
Pharmacokinetic (PK) CL/F
Pharmacokinetic (PK) parameters from plasma samples
Measured: Day 147
Pharmacokinetic (PK) Vz/F
Pharmacokinetic (PK) parameters from plasma samples
Measured: Day 147
Pharmacokinetic (PK) Cmax
Pharmacokinetic (PK) parameters from plasma samples
Measured: Day 147
Pharmacokinetic (PK) AUCtau
Pharmacokinetic (PK) parameters from plasma samples
Measured: Day 147
Pharmacokinetic (PK) Tmax
Pharmacokinetic (PK) parameters from plasma samples
Measured: Day 147
Overall response rate (ORR)
To evaluate preliminary anti-tumor activity
Measured: Approximately 48 Months
Duration of response (DoR)
To evaluate preliminary anti-tumor activity
Measured: Approximately 48 Months
Time to response (TTR)
To evaluate preliminary anti-tumor activity
Measured: Approximately 48 Months
Progression-free survival (PFS)
To evaluate preliminary anti-tumor activity
Measured: Approximately 48 Months
Overall Survival (OS)
To evaluate preliminary anti-tumor activity
Measured: Approximately 48 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start2 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin Lymphoma (NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NOBO Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07114367
- Sponsor's protocol ID
- NB02-L02
- Acronym
- POTENTIAL-M
- Status last verified
- Jan 2026
- First submitted
- 3 Jul 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07114367
- Acronym / sponsor ID
- POTENTIAL-M / NB02-L02
- Conditions
- Non Hodgkin Lymphoma (NHL)
- Keywords
- Relapsed, Refractory, Lymphoma, NHL, FL, MCL, MZL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- NOBO MedicineIndustry (pharma, biotech, devices)
- Study start
- 2 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NB02 (Poseltinib) | Experimental | Drug: NB02 (Poseltinib)Dose Level 1 Dose Level 2 Dose Level 3 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NB02 (Poseltinib)Dose Level 1, Dose Level 2, Dose Level 3 | Drug | NB02 (Poseltinib) |
Primary outcome
MTD(maximum tolerated dose) or OBD(optimal biological dose)
Time frame: Approximately 48 Months
MTD(maximum tolerated dose) or OBD(optimal biological dose)
AEs
Time frame: Approximately 48 Months
AEs
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
Related trials for Non Hodgkin Lymphoma (NHL)
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NB02 (Poseltinib) in people with Non Hodgkin Lymphoma (NHL), run by NOBO Medicine at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD(maximum tolerated dose) or OBD(optimal biological dose) (time frame: Approximately 48 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.