A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma

Recruiting now · Phase 2

Conditions studied: B-cell Lymphoma

In brief

To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma

Key facts

Study ID

NCT06566586

Run by

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

People needed

80

Starts

2024-11-06

Expected to finish

2027-12-01

Last updated by the study team

2024-11-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
• Age: 18 years old ≤ age (when signing the informed consent) ≤75 years old; Eastern cooperative oncology group (ECOG) score: 0-2; Expected survival of more than 3 months;
• Histologically confirmed B-cell lymphomas of the following types that meet the 2022 World Health Organization (WHO) diagnostic criteria:
• Relapsed/refractory indolent B-cell lymphoma
• Diffuse large B cell lymphoma（DLBCL）
• Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received at least one previous line of systemic standard therapy
• Have at least one measurable lesion.
• The main organs function well.
• Female subjects of reproductive age should agree to use contraception (such as Iuds, contraceptives, or condoms) during the study period 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 subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.

You may not qualify if…

• Have had or are currently suffering from other malignant tumors within 3 years prior to the first medication.
• Known or suspected central nervous system (CNS) aggression.
• Relapsed/refractory inert B-cell lymphoma: previous allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 3 months before the first treatment;
• Recurrent/refractory indolent B-cell lymphoma: toxic reactions that do not return to ≤ National Cancer Institute standard for common toxic reactions (NCI-CTC) AE Grade 1 due to any previous treatment, excluding hair loss and fatigue;
• Have multiple factors that affect oral drug absorption (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
• Received major surgical treatment or significant traumatic injury within 28 days before the start of study treatment;
• Hyperkinetic/venous thrombosis events occurred within 6 months before the first medication;
• Have a history of psychotropic drug abuse and can not quit or have mental disorders;
• Subjects with any severe and/or uncontrolled disease;
• Received live vaccine or messenger ribonucleic acid (mRNA) vaccine within 4 weeks before the first dose, or planned to receive live vaccine or mRNA vaccine during the study;
• Participated in clinical trials of other antitumor drugs within 4 weeks before the first medication;
• Subjects who, in the judgment of the investigator, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons.

Where it is running

• Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (enrolling)
• Gansu Provincial Cancer Hospital — Lanzhou, Gansu, China
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
• Guigang City People's Hospital — Guigang, Guangxi, China
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• PuYang AnYang District Hospital — Anyang, Henan, China
• Puyang People's Hospital — Puyang, Henan, China
• Henan Provincial People's Hospital — Zhengzhou, Henan, China
• Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China
• Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy — Wuhan, Hubei, China
• Tongji Hospital Tongji Medical College of HUST — Wuhan, Hubei, China
• Xiangyang Central Hospital — Xiangyang, Hubei, China
• Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University — Changsha, Hunan, China
• Zhuzhou Central Hospital — Zhuzhou, Hunan, China
• The Affiliated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• The second Hospital of dalian — Dalian, Liaoning, China
• The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital) — Xi'an, Shaanxi, China
• Tai'an Central Hospital — Tai’an, Shandong, China
• Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, China
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China
• The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China

Full record on ClinicalTrials.gov

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