A Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma（PTCL）

Study Overview
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Brief Summary
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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.

Official Title
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A Single-arm, Open-label, Multi-center, Phase II Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)

Conditions
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Peripheral T-cell Lymphoma

Intervention / Treatment
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* Drug: TQ-B3525


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TQ-B3525 tablets<br>TQ-B3525 tablet administered orally. | Drug: TQ-B3525<br>* TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) by Independent Review Committee | Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (ORR) assessed by Investigator | Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator. | up to 6 months | 
| Duration of response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | up to 12 months | 
| Progression-free survival (PFS) | PFS was defined as the time from the date of study enrollment to the date of the first of the following events, objective disease progression or death due to any cause. | up to 6 months | 
| Disease control rate（DCR） | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 12 months | 
| Overall survival(OS) | OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up. | up to 24 months |