A Study of TQ-B3525 in Subjects With Relapse/Refractory Diffuse Large B-cell Lymphoma （DLBCL）

A Single-arm, Open-label, Multicenter, Phase II Clinical Trials of TQ-B3525 in Subjects With Relapse/Refractory Diffuse Large B-cell Lymphoma （DLBCL）

This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapse/refactory diffuse large B-cell lymphoma who have received at least 2 lines of therapeutic schedules including rituximab. TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B-cell Lymphoma
• Intervention / Treatment: Drug: TQ-B3525 tablets

• Study Type: Interventional
• Enrollment (Anticipated): 93
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Not yet recruiting
      • Cancer Hospital, Chinese Academy of Medical Sciences
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Beijing Hospital
      • Contact: Hui Liu, Doctor; Email: liuhui8140@126.com
      • Principal Investigator: Hui Liu, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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. Relapsed/refractory Diffuse Large B-cell lymphoma （DLBCL); 4. Has received at least two lines of previous treatment, the latest treatment confirmed no objective response, or disease progress after treatment, either of the treatment should conclude rituximab; 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. DLBCL transformed from previously diagnosed indolent 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 a history of immunodeficiency diseases; 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 administration; 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 within 4 weeks before the first administration; 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, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TQ-B3525 tablets; TQ-B3525 tablet administered orally.	Drug: TQ-B3525 tablets; TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall response rate (ORR) assessed by Independent Review Committee	Percentage of participants achieving complete response (CR) and partial response (PR) based on IRC	Baseline up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline up to 18 months
Disease control rate（DCR）	Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).	Baseline up to 18 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.	Baseline up to 24 months
Overall response rate (ORR) assessed by Investigator	Percentage of participants achieving complete response (CR) and partial response (PR) assessed by investigator.	Baseline up to 18 months

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2021
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): June 30, 2022

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (ACTUAL): November 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID Numbers: TQ-B3525-II-05

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No