Clinical trial · Interventional
A Study of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)
A Single-arm, Multicenter Phase II Clinical Trial of TQ-B3525 Tablet in the Treatment of Relapsed / Refractory Mantle Cell Lymphoma (MCL)
NCT04398953CI-TRIAL-00047105unknownPhase 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 safety and efficacy of TQ-B3525 tablets in patients with relapsed / refractory mantle cell lymphoma (MCL).
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 |
|---|---|---|---|
| Relapsed / Refractory Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TQ-B3525 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TQ-B3525 tablet
- description
- TQ-B3525 tablet administered orally.
- interventionNames
- Drug: TQ-B3525
Primary outcomes (1)
- measure
- Objective response rate (ORR) assessed by Independent Review Committee (IRC)
- timeFrame
- up to 12 months
- description
- Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
Secondary outcomes (5)
- measure
- Disease control rate(DCR)
- timeFrame
- up to 12 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. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥ 3 months; 3. Relapsed / refractory MCL; 4. Has received at least one-line and less than four lines of previous treatment, the latest treatment confirmed no objective response, or disease progress after 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\. Has central nervous system violation; 2. Has received other PI3K inhibitors; 3. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 4. Has history of interstitial lung disease; 5. Has a history of immunodeficiency diseases; 6. Has multiple factors affecting oral medication; 7. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 8. Has received systemic steroid treatment within 7 days before the first administration; 9. 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; 10. Has palliative radiation therapy within 4 weeks before the first administration; 11. Has active infections within 4 weeks before the first administration; 12. Has received surgery, or unhealed wounds within 4 weeks before the first administration; 13. Has a history of autologous hematopoietic stem cell transplant within 6 months or allogeneic hematopoietic stem cell transplant; 14. QTCF \> 480ms, LVEF \< 50%; 15. Urinary protein ≥ 2 +, and urinary protein quantity \>1.0 g in 24 hours within 7 days; 16. Has active hepatitis B or C; 17. Has psychotropic substances abuse or a mental disorder; 18. 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.