Peripheral T Cell LymphomaPhase 2NCT07180771
A Study of Bosmolisib (BR101801) in Participants With R/R PTCL.
A Phase 2 study testing BR101801 in people with Peripheral T Cell Lymphoma, run by Boryung Pharmaceutical Co., Ltd.
Trial summary
The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peripheral T Cell Lymphoma
- What is being tested?
- BR101801
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Sep 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The ECOG performance status ≤ 2.
- Life expectancy more than 3 months.
- Patients with relapsed and/or refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification
- Peripheral T-cell lymphoma, not otherwise specified
- Nodal TFH cell lymphoma, angioimmunoblastic-type
- Nodal TFH cell lymphoma, follicular-type
Show all 9Show fewer
- Nodal TFH cell lymphoma, NOS
- Patients currently requiring systemic therapy at the investigator's discretion.
- Patients with a lesion measuring 1.5 cm or more in its longest transverse diameter, as determined by CT, PET/CT or MRI scans according to the 2014 Lugano criteria.
Who cannot join
- The presence of overt leptomeningeal or active central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks.
- Impaired cardiac function or clinically significant cardiac disease.
- Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.
- For patients with lymphoma:
- Systemic antineoplastic therapy (including cytotoxic chemotherapy, alfa-interferon [INF], and toxin immunoconjugates) or any experimental therapy within 3 weeks or 5 half lives, whichever is shorter, before the first dose of study treatment.
- Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
- Unconjugated monoclonal antibody therapies < 6 weeks before the first dose of study treatment.
- Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (>20 mg/day prednisone or equivalent).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II, Single-arm, Multicenter, Open Label Study to Evaluate Efficacy and Safety of BR101801 Monotherapy in Relapsed/Refractory Peripheral T-cell Lymphoma Patients
The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
Read the detailed description
This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.
- Conditions
- Peripheral T Cell Lymphoma
- Being tested
- BR101801
- Keywords
- PTCL, Bosmolisib, BR101801, PI3K inhibitor, DNA-PK
- Medical subject headings
- Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BR101801Drug
Also called Bosmolisib
Patients will receive 200mg capsules (100mg+100mg)
| Study group | Role | What they receive |
|---|---|---|
| BR101801 (Bosmolisib) | Experimental | Patients will receive BR101801 capsules orally, QD in 28-day cycles Receives: Drug: BR101801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
Measured: Up to 2 years
Secondary outcomes (10)
Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
Measured: Up to 2 years
Overall Survival (OS)
Measured: Up to 2 years
Disease Control Rate (DCR)
Measured: Up to 2 years
Duration of Response (DOR)
Measured: Up to 2 years
Progression-free Survival (PFS)
Measured: Up to 2 years
Time to Tumor Progression (TTP)
Measured: Up to 2 years
Quality of life assessment Using the EQ-5D-5L assessment
European quality of life 5 dimensions questionnaire. The values is 0 to 1, whereby 0 indicates death and 1 perfect health
Measured: Every 2 cycles for up to 24 months (each cycle is 28 days)
Quality of life assessment Using EORTC QLQ-C30 assessment
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, EORTC QLQ-C30). All of the scales and single-item measures range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: Every 2 cycles for up to 24 months (each cycle is 28 days)
Plasma Concentration of BR101801 (Bosmolisib)
Blood samples were taken for the analyses of BR101801 in plasma at designated time points.
Measured: Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days)
Adverse events
Measured: Approximately 24 months after a consent to the participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study startFeb 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Boryung Pharmaceutical Co., LtdThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boryung Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180771
- Sponsor's protocol ID
- BR-101801-CT-201
- Status last verified
- Jan 2026
- First submitted
- 4 Sep 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm, Multicenter, Open Label Study to Evaluate Efficacy and Safety of BR101801 Monotherapy in Relapsed/Refractory Peripheral T-cell Lymphoma Patients
- ClinicalTrials.gov ID
- NCT07180771
- Acronym / sponsor ID
- BR-101801-CT-201
- Conditions
- Peripheral T Cell Lymphoma
- Keywords
- PTCL, Bosmolisib, BR101801, PI3K inhibitor, DNA-PK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Sep 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.
The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
Detailed description
This phase II study will evaluate the efficacy and safety of single-dose BR101801 once daily in patients with peripheral T-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BR101801 (Bosmolisib) | Experimental | Drug: BR101801Patients will receive BR101801 capsules orally, QD in 28-day cycles |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The ECOG performance status ≤ 2.
- Life expectancy more than 3 months.
- Patients with relapsed and/or refractory to standard therapy or are intolerance to standard therapy diagnosed with 2022 World Health Organization (WHO) classification
- Patients currently requiring systemic therapy at the investigator's discretion.
- Patients with a lesion measuring 1.5 cm or more in its longest transverse diameter, as determined by CT, PET/CT or MRI scans according to the 2014 Lugano criteria.
Key exclusion criteria (8 listed)
- The presence of overt leptomeningeal or active central nervous system (CNS) metastases, or CNS metastases that require local CNS-directed therapy or increasing doses of corticosteroids within the prior 2 weeks.
- Impaired cardiac function or clinically significant cardiac disease.
- Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis.
- For patients with lymphoma:
- Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (>20 mg/day prednisone or equivalent).
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 |
|---|---|---|
| BR101801Also: BosmolisibPatients will receive 200mg capsules (100mg+100mg) | Drug | BR101801 (Bosmolisib) |
Primary outcome
Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
Time frame: Up to 2 years
10 secondary outcomes
Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-free Survival (PFS)
Time frame: Up to 2 years
Time to Tumor Progression (TTP)
Time frame: Up to 2 years
Quality of life assessment Using the EQ-5D-5L assessment
Time frame: Every 2 cycles for up to 24 months (each cycle is 28 days)
Quality of life assessment Using EORTC QLQ-C30 assessment
Time frame: Every 2 cycles for up to 24 months (each cycle is 28 days)
Plasma Concentration of BR101801 (Bosmolisib)
Time frame: Cycle 2 Day 1 and Day 1 of Cycle 3 (each cycle is 28 days)
Adverse events
Time frame: Approximately 24 months after a consent to the participation
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 28 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Peripheral T Cell Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
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
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)
Relapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BR101801 in people with Peripheral T Cell Lymphoma, run by Boryung Pharmaceutical Co., Ltd.
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 9 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Shinyoung Oh (+82 2-708-8000, syoh@boryung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria (time frame: Up to 2 years). 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 28 Jan 2026.