Clinical trial · Interventional
A Study of Bosmolisib (BR101801) in Participants With R/R PTCL.
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
NCT07180771CI-TRIAL-00101786not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of this phase II study is to evaluate the efficacy and safety of BR101801 in patients with peripheral T-cell lymphoma(PTCL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BR101801 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BR101801 (Bosmolisib)
- description
- Patients will receive BR101801 capsules orally, QD in 28-day cycles
- interventionNames
- Drug: BR101801
Primary outcomes (1)
- measure
- Confirmed Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
- timeFrame
- Up to 2 years
Secondary outcomes (10)
- measure
- Objective Response Rate (ORR) (CR + PR) assessed by a blinded independent reviewer at the central lab according to the 2014 Lugano criteria
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. The ECOG performance status ≤ 2. 2. Life expectancy more than 3 months. 3. 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 * Nodal TFH cell lymphoma, NOS 4. Patients currently requiring systemic therapy at the investigator's discretion. 5. 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: 1. 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. 2. Impaired cardiac function or clinically significant cardiac disease. 3. Patients with interstitial pneumonia or history of drug-induced interstitial pneumonia/pneumonitis. 4. 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. 5. Patients receiving systemic chronic steroid therapy or any immunosuppressive therapy (\>20 mg/day prednisone or equivalent).
References
Publications (0)
Data not yet available
No reference posted for this study.