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

• ClinicalTrials.gov Identifier: NCT04615468
• Recruitment Status: Not yet recruiting
• First Posted: November 4, 2020
• Last Update Posted: November 4, 2020
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Information provided by (Responsible Party): Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Peripheral T-cell Lymphoma	Drug: TQ-B3525	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 78 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-arm, Open-label, Multi-center, Phase II Study of TQ-B3525 in Subjects With Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)
• Estimated Study Start Date: December 1, 2020
• Estimated Primary Completion Date: October 31, 2021
• Estimated Study Completion Date: October 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: TQ-B3525 tablets; TQ-B3525 tablet administered orally.	Drug: TQ-B3525; TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.

Outcome Measures

Primary Outcome Measures :

1. Overall response rate (ORR) by Independent Review Committee [ Time Frame: up to 6 months ]
   Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC.

Secondary Outcome Measures :

1. Overall response rate (ORR) assessed by Investigator [ Time Frame: up to 6 months ]
   Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.
2. Duration of response (DOR) [ Time Frame: up to 12 months ]
   DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
3. Progression-free survival (PFS) [ Time Frame: up to 6 months ]
   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.
4. Disease control rate（DCR） [ Time Frame: up to 12 months ]
   Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
5. Overall survival(OS) [ Time Frame: up to 24 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Yuankai Shi, Doctor; 010-87788293; syuankaipumc@126.com

Locations

China, Beijing

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing, China, 100083

China, Shanghai

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai, China, 200092

Sponsors and Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

More Information

• Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04615468
• Other Study ID Numbers: TQ-B3525-II-04
• First Posted: November 4, 2020
• Last Update Posted: November 4, 2020
• Last Verified: July 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin