Clinical trial · Interventional
A Study of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
A Open-label, Single-arm, Multicenter Phase Ⅱ Clinical Trial of TQ-B3525 in the Treatment of Relapsed / Refractory Follicular Lymphoma (FL)
NCT04324879CI-TRIAL-00045744unknownPhase 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 study is to evaluate the efficacy of TQ-B3525 in patients with relapsed / refractory follicular lymphoma.
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 Follicular Lymphoma | Follicular Lymphoma | 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 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
- Baseline up to 18 months
- description
- Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Secondary outcomes (7)
- measure
- Progression-free survival (PFS)
- timeFrame
- Baseline up to 18 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 or 1; Life expectancy ≥ 3 months. 3\. Relapsed / refractory FL. 4. At least one measurable lymph node or extranodal lymphoma lesions. 5. Adequate organ system function. 6. 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 diagnosed and/or treated additional malignancy within 3 years prior to the first administration. 2\. Has a history of immunodeficiency diseases. 3. Has multiple factors affecting oral medication. 4. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1. 5\. Has received systemic steroid treatment within 7 days before the first administration. 6\. 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. 7\. Has palliative radiation therapy within 4 weeks before the first administration. 8\. Has received surgery, or unhealed wounds within 4 weeks before the first administration. 9\. Has a history of autologous hematopoietic stem cell transplant within 3 months or allogeneic hematopoietic stem cell transplant within 6 months. 10.Has cardiovascular disease ≥grade 2 within 6 months before the first administration. 11\. Has active hepatitis B or C. 12. Has psychotropic substances abuse or a mental disorder. 13.Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
References
Publications (1)
- DERIVEDWang H, Feng J, Liu Y, Qian Z, Gao D, Ran X, Zhou H, Liu L, Wang B, Fang M, Zhou H, Huang Z, Tao S, Chen Z, Su L, Su H, Yang Y, Xie X, Wu H, Sun P, Hu G, Liang A, Li Z. Phase II study of novel orally PI3Kalpha/delta inhibitor TQ-B3525 in relapsed and/or refractory follicular lymphoma. Signal Transduct Target Ther. 2024 Apr 17;9(1):99. doi: 10.1038/s41392-024-01798-0. PMID 38627366