TQB3909 Tablets in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06106841
• Collaborator: (none)
• Enrollment: 39
• Locations: 28
• Arms: 2
• Anticipated Duration (Months): 13.9
• Patients Per Site: 1.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

This is a study to assess the safety of TQB3909 monotherapy in participants with relapsed or refractory MCL.

Condition or Disease	Intervention/Treatment	Phase
Mantle Cell Lymphoma	Drug: 400mg of TQB3909 tablets; Drug: 600mg of TQB3909 tablets	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase Ib/II Clinical Trial of TQB3909 Tablets in Subjects With Relapsed or Refractory MCL Safety and Efficacy
• Actual Study Start Date: Oct 5, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 400mg of TQB3909 tablets tablet, 28 days as a treatment cycle.	Drug: 400mg of TQB3909 tablets; TQB3909 tablets 400mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.
Experimental: 600mg of TQB3909 tablets tablet, 28 days as a treatment cycle.	Drug: 600mg of TQB3909 tablets; TQB3909 tablets 600mg, TQB3909 tablets is a B-cell lymphoma (BCL)-2 inhibitor.

Outcome Measures

Primary Outcome Measures

1. Recommended phase II dose (RP2D) [Baseline up to 48-weeks]

   Recommended phase II dose (RP2D)

Secondary Outcome Measures

1. The incidence of adverse events (AEs) [Baseline up to 96-weeks]

   Number of participants with adverse events (AE) and/or severe adverse events (SAE) and/or abnormal laboratory examination indicators.

2. The severity of adverse events (AEs) [Baseline up to 96-weeks]

   The severity of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

3. The severity of severe adverse events (SAEs) [Baseline up to 96-weeks]

   The severity of severe adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

4. The severity of abnormal laboratory examination indicators [Baseline up to 96-weeks]

   The severity of abnormal laboratory examination indicators as assessed by Common Terminology Criteria for Adverse Events (CTCAE) 5.0.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subject voluntarily joins the study, signs the informed consent form, and has good compliance;

• Age: ≥ 18 years old (when signing the informed consent form); Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-2 points; Expected survival is more than 3 months;

• Subject population: Confirmed as MCL by local laboratory pathology and independent pathology review (stage 2).

• The main organs are functioning well,

• The patient's Computed Tomography (CT) / Magnetic Resonance Imaging (MRI) shows measurable lesions, defined as ≥ 1 lymph node with the longest diameter of > 1.5 cm or ≥ 1 extranodal lesion with the longest diameter of > 1.0 cm, which can be measured by ≥ 2 vertical dimensions;

• Female subjects of childbearing age should agree to use contraception (e.g., pills, or condoms) during the study and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.

Exclusion Criteria:

• Have had or currently have other malignant tumors within 3 years before the first dose of study drug.

• It is known that lymphoma affects the central nervous system (CNS);

• Previous allogeneic hematopoietic stem cell transplantation;

• Have received autologous hematopoietic stem cell transplantation within 3 months before the first dose of study drug;

• There are a variety of factors that affect oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, inflammatory bowel disease, malabsorption syndrome, etc.);

• Unmitigated toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 due to any prior treatment (except hair loss, absolute neutrophil count and platelet abnormalities, which follow the inclusion criteria 4);

• Significant surgical treatment and obvious traumatic injury within 28 days prior to the start of study treatment;

• Arteriovenous thrombotic events within 3 months before the first dose, such as cerebrovascular accident (including cerebral hemorrhage, cerebral infarction, except lacunar cerebral infarction), deep vein thrombosis (except secondary to deep vein catheterization) and pulmonary embolism;

• Those who have a history of psychotropic substance abuse and cannot be withdrawn or have mental disorders;

• Subjects with any severe and/or uncontrolled medical conditions, including:

• Grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (Quick Time Constant Fluctuation (QTcF) >450 ms in men, QTcF >470 ms in women) and grade ≥2 congestive heart failure (New York Heart Association (NYHA) grade), cardiac ultrasound assessment of left ventricular ejection fraction (LVEF) of <50%; poorly controlled hypertension, defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg at least 2 consecutive blood pressure measurements at the time of screening；

• presence of active infection (≥ CTCAE grade 2 infection);

• active hepatitis; Hepatitis B virus (HBV) infection, HBV DNA positive or copy number exceeding the upper limit of normal values in the research center;

• Have a history of immunodeficiency, including Human Immunodeficiency Virus(HIV)-positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;

• Those who have epilepsy and need treatment.

• Have received chemotherapy and radiotherapy within 4 weeks before the first dose, received immune checkpoint inhibitors and Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) therapy 12 weeks before the first dose, and received other small molecule antitumor therapy (elution period from the end of the last treatment) before the first drug use within 5 half-lives;

• Previous treatment with BCL-2 inhibitors;

• Have received a live vaccine within 4 weeks prior to the first dose, or plan to be vaccinated during the study;

• Have participated in other antitumor drug clinical trials within 4 weeks before the first dose;

• According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.

• Allergic to allopurinol and benzbromarone.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Third Hospital	Beijing	Beijing	China	100191
2	Chongqing University Hospital	Chongqing	Chongqing	China	400030
3	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian	China	361003
4	Gansu Provincial Cancer Hospital	Lanzhou	Gansu	China	730050
5	Guangxi Medical University Cancer Hospital	Nanning	Guangxi	China	530021
6	The Affiliated Hospital of Chengde Medical College	Chengde	Hebei	China	067000
7	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150001
8	Affiliated Cancer Hospital of Harbin Medical University	Harbin	Heilongjiang	China	150081
9	Henan Cancer Hospital	Zhengzhou	Henan	China	450000
10	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology	Wuhan	Hubei	China	430050
11	The Affiliated Hospital of Xuzhou Medical University	Nanjing	Jiangsu	China	220005
12	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215004
13	The First Affiliated Hospital Of Soochow University	Suzhou	Jiangsu	China	215006
14	Jinzhou Central Hospital	Wuxi	Jiangsu	China	530031
15	Jilin Cancer Hospital	Changchun	Jilin	China	130012
16	The First Hospital of Jilin University	Changchun	Jilin	China	130022
17	The Second Hospital of Dalian Medical University	Dalian	Liaoning	China	116000
18	Binzhou Medical University Hospital	Binzhou	Shandong	China	256603
19	Linyi People's Hospital	Linyi	Shandong	China	276000
20	Shanghai Huashan Hospital	Shanghai	Shanghai	China	200040
21	Tongji hospital of Tongji University	Shanghai	Shanghai	China	200065
22	Heping Hospital Affiliated to Changzhi Medical College	Changzhi	Shanxi	China	046000
23	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan	China	646000
24	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin	China	300040
25	Institute of Dematology & Blood diseases Hospital	Tianjin	Tianjin	China	300052
26	Xinjiang Uygur Autonomous Region People's Hospital	Ürümqi	Xinjiang	China	830001
27	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310003
28	The First Affiliated Hospital of Ningbo University	Ningbo	Zhejiang	China	215006

Sponsors and Collaborators

• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT06106841
• Other Study ID Numbers: TQB3909-Ib/II-04
• First Posted: Oct 30, 2023
• Last Update Posted: Oct 30, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Mantle-Cell

Study Results

No Results Posted as of Oct 30, 2023