Clinical trial · Interventional
A Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma(PTCL)
A Single-arm, Open-label, Multi-center, Phase II Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)
NCT04615468CI-TRIAL-00048085unknownPhase 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)
This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory peripheral T-cell lymphoma who have received at least 1 lines of therapeutic schedules. TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
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 |
|---|---|---|---|
| TQ-B3525 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQ-B3525 tablets
- description
- TQ-B3525 tablet administered orally.
- interventionNames
- Drug: TQ-B3525
Primary outcomes (1)
- measure
- Overall response rate (ORR) by Independent Review Committee
- timeFrame
- up to 6 months
- description
- Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.
Secondary outcomes (5)
- measure
- Overall response rate (ORR) assessed by Investigator
- timeFrame
- up to 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Understood and signed an informed consent form; 2. 18 years and older, Eastern Cooperative Oncology Group(ECOG) performance status score of 0 to 2, life expectancy ≥ 3 months; 3. Diagnosis of peripheral T-cell lymphoma (PTCL); 4. Has received at least one line systemic treatment and disease progression after the last treatment; 5. Has at least one measurable lesion; 6. Adequate organ system function; 7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration. Exclusion Criteria: * 1\. Other types of T-cell lymphoma; 2. Has central nervous system violation; 3. Has received other PI3K inhibitors or CAR-T treatments; 4. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 5. Has type I diabetes or uncontrolled type II diabetes; 6. Has history of interstitial lung disease; 7. Has history of interstitial lung disease; 8. Has multiple factors affecting oral medication; 9. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. Has received systemic steroid treatment within 7 days before the first dose; 11. Has received other systemic anti-tumor medications within 4 weeks before the first administration, or still within the 5 half-life of the medication, which occurs first; 12. Has active infections which need drug treatment; 13. Has received surgery, or unhealed wounds within 4 weeks before the first administration; 14. Has a history of autologous hematopoietic stem cell transplant within 3 months; 15. Has a history of allogeneic hematopoietic stem cell transplant; 16. Grade II or higher cardiovascular disease within 6 months before the first administration; 17. QTCF \> 480ms, left ventricular ejection fraction (LVEF)\<50%; 18. Urinary protein ≥ 2 +, and 24-hour urinary protein quantity\>1g within 7 days; 19. Has active hepatitis B or C; 20. Has psychotropic substances abuse or a mental disorder; 21.Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
References
Publications (0)
Data not yet available
No reference posted for this study.