A Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

A Single-arm, Open-label, Multi-center Phase Ib/II Study of TQ-B3525 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma(CLL/SLL)

This is a study to evaluate the efficacy and safety of TQ-B3525 in subjects with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

Study Overview

• Status: Terminated
• Conditions: Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
• Intervention / Treatment: Drug: TQ-B3525 tablets

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First People's Hospital
    • Guangzhou, Guangdong, China, 510120
      • The First Affiliate Hospital of Guangzhou Medical University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • Guiyang, Guizhou, China, 550004
      • The Affiliated Hospital Of Guizhou Medical University
  • Hunan
    • Changsha, Hunan, China, 410008
      • The Second Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute & Hospital
    • Tianjin, Tianjin, China, 300050
      • Tianjin Medical University General Hospital
    • Tianjin, Tianjin, China
      • Hematology Hospital of Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

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

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.Chronic lymphocytic leukemia/small lymphocytic lymphoma diagnosed by flow cytometry or pathology, and meets at least one of the criteria for active diseases requiring treatment in IWCLL2008; 4.Has received at least one line 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 Richter's transformation or prolymphocytic leukemia (PLL)； 2. Has central nervous system violation; 3. Has uncontrolled primary autoimmune cytopenias, including autoimmune hemolytic anemia (AIHA), idiopathic thrombocytopenic purpura (ITP), etc； 4. Has received other PI3K inhibitors or CAR-T treatments; 5. Has diagnosed and/or treated additional malignancy within 3 years prior to the first administration; 6.Diagnosed as type I diabetes or uncontrollable type II diabetes, or fasting blood glucose> 8.9 mmol/L or glycosylated hemoglobin (HbA1c)> 8.5% during the screening period; 7. Has interstitial lung disease or drug-induced interstitial lung disease history; 8. Has a history of immunodeficiency diseases; 9. Has multiple factors affecting oral medication; 10. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 11. Has received systemic steroid treatment within 7 days before the first administration; 12. 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; 13.Has active infections within 4 weeks before the first administration; 14.Has received surgery, or unhealed wounds within 4 weeks before the first administration; 15. Has a history of autologous hematopoietic stem cell transplant within 3 months; 16. Has a history of allogeneic hematopoietic stem cell transplant; 17. Grade II or higher cardiovascular disease within 6 months before the first administration; 18.QTCF > 480ms, LVEF < 50%; 19.Urinary protein ≥ 2 +, and 24-hour urinary protein quantity>1g within 7 days; 20. Has active hepatitis B or C; 21. Has psychotropic substances abuse or a mental disorder; 22. Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.

21. Has psychotropic substances abuse or a mental disorder;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

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
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
Duration of disease remission (DOR)	The time from the first evaluation of the subject as CR or PR to the first evaluation of the subject as PD or death (whichever occurs first).	Baseline up to 18 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	Baseline up to 18 months
Incidence of Adverse Events, Serious Adverse Events	AE, SAE, and withdrawal from the trial for reasons such as safety or tolerability.	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): June 5, 2021
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): November 22, 2023

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Lymphoma; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: TQ-B3525-Ib/II-06

Drug and device information, study documents

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