B-cell LymphomaPhase 2NCT06566586
A Clinical Study to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
A Phase 2 study testing TQB3702 tablets+Chemotherapy regimen in people with B-cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 30 sites in China.
Trial summary
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Lymphoma
- What is being tested?
- TQB3702 tablets+Chemotherapy regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 30 sitesChina
- Study dates
- 6 Nov 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites, 30 recruiting
- Not yet recruiting
PuYang AnYang District Hospital
Anyang, Henan, 450000
Junxia Meng, Bachelor, 13526194738, 3086256729@qq.com
- Not yet recruiting
Cancer Hospital Chinise Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Peng Liu, Doctor, 13910216310, 13910216310@163.com
- Not yet recruiting
Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, 410013
Yajun Li, Doctor, 18273175031, liyajun@hnca.org.cn
- Not yet recruiting
The second Hospital of dalian
Dalian, Liaoning, 116000
Xiuhua Sun, Master, 17709873631, 3038668@vip.sina.com
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Hua Wang, Doctor, 15920352412, wanghua@sysucc.org.cn
- Not yet recruiting
Guigang City People's Hospital
Guigang, Guangxi, 537000
Yi Huang, Bachelor, 15977590866, huangyi236@126.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Qingyuan Zhang, Doctor, 13313612989, sy86298276@163.com
- Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 10000
Da Gao, Master, 13947130473, Gaoda72@163.com
- Recruiting
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
Zengjun Li, Doctor, 13642138692, zengjunli@163.com
- Not yet recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730000
Junfeng Jiang, Doctor, 13893332604, 13893332604@163.com
- Not yet recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
XiaoMing Li, Master, 13700986866, Lxm6358@21cn.com
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fei Li, Doctor, 13970038386, yx021021@sina.com
- Not yet recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000
Lei Fan, Doctor, 13813976136, fanlei3014@126.com
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Hong Cen, Doctor, 13507711671, cen_hong@163.com
- Not yet recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021
Xiaohong Tan, Doctor, 13877193237, tanxhong@163.com
- Not yet recruiting
Puyang People's Hospital
Puyang, Henan, 457000
Zhichun Li, Master, 13839313232, 13839313232@163.com
- Not yet recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200063
Ping Li, Doctor, 13564181131, Lilyforever76@126.com
- Not yet recruiting
Tai'an Central Hospital
Tai’an, Shandong, 271000
Ling Wang, Doctor, 13583897631, 13583897631@163.com
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Liping Su, Doctor, 13835158122, slpsy2022@163.com
- Not yet recruiting
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300122
Huaqing Wang, Doctor, 18622221223, wanghuaqing@163.com
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300202
Shiyong Zhou, Doctor, 13820041468, Zsy1003@163.com
- Not yet recruiting
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Shujuan Wen, Doctor, 18160631686, 736587502@qq.com
- Not yet recruiting
Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
Wuhan, Hubei, 430022
Fang Zhu, Doctor, 13871545106, zhufang1226@126.com
- Not yet recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, 430030
Yi Xiao, Doctor, 13036120269, yixiao@tjmu.tjh.edu.cn
- Not yet recruiting
The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
Xi'an, Shaanxi, 710004
Wanhong Zhao, Doctor, 18991908852, 13991365406@163.com
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441000
Quan Li, Doctor, 13972099899, 124993699@qq.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Zunmin Zhu, Doctor, 13603712008, zhuzm1964@163.com
- Not yet recruiting
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
Zhengzhou, Henan, 457000
Keshu Zhou, Master, 13674902391, drzhouks77@163.com
- Not yet recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000
Chanjuan Shen, Master, 18973389928, Shenchanjuan@163.com
- Not yet recruiting
Zigong First People's Hospital
Zigong, Sichuan, 643000
Jian Xiao, Master, 15881327002, 16188702@qq.com
About this study
Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
- Conditions
- B-cell Lymphoma
- Being tested
- TQB3702 tablets+Chemotherapy regimen
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3702 tablets+Chemotherapy regimenDrug
TQB3702 tablets: Tyrosine kinase inhibitor；
Chemotherapy regimen：inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis；
| Study group | Role | What they receive |
|---|---|---|
| TQB3702 tablets+Chemotherapy regimen | Experimental | TQB3702 tablets 200mg, every 4 weeks for a treatment cycle.
Chemotherapy regimen：Every 3 or 4 weeks is a treatment cycle, with 6 or 12 cycles of combination therapy Receives: Drug: TQB3702 tablets+Chemotherapy regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Measured: Up to 2 years
Complete response rate (CRR)
The rate of complete tumor remission
Measured: Up to 2 years
Secondary outcomes (7)
Adverse events (AE) and serious adverse events (SAE)
Incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators
Measured: Baseline to up to 28 days
ORR and CRR at the end of combination therapy
Objective response rate and complete remission rate at the end of combination therapy.
Measured: Up to 1 year
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measured: Up to 2 years
Duration of response (DOR)
The period from the participants first achieving CR or PR to disease progression
Measured: Up to 2 years
Overall survival (OS)
OS is defined as the time from the first administration to all-cause death
Measured: Up to all-cause death
1-year PFS and OS
1-year Progression-free survival and Overall survival rates
Measured: Up to 1 year
2-years PFS and OS
2-years Progression-free survival and Overall survival rates
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start6 Nov 2024
- Primary completionMar 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566586
- Sponsor's protocol ID
- TQB3702-II-02
- Status last verified
- Apr 2024
- First submitted
- 21 Aug 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB3702 Tablets Combined With Immunochemotherapy for the Treatment of B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06566586
- Acronym / sponsor ID
- TQB3702-II-02
- Conditions
- B-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3702 tablets+Chemotherapy regimen | Experimental | Drug: TQB3702 tablets+Chemotherapy regimenTQB3702 tablets 200mg, every 4 weeks for a treatment cycle. Chemotherapy regimen：Every 3 or 4 weeks is a treatment cycle, with 6 or 12 cycles of combination therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB3702 tablets+Chemotherapy regimenTQB3702 tablets: Tyrosine kinase inhibitor； Chemotherapy regimen：inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis； | Drug | TQB3702 tablets+Chemotherapy regimen |
Primary outcome
Overall response rate (ORR)
Time frame: Up to 2 years
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment.
Complete response rate (CRR)
Time frame: Up to 2 years
The rate of complete tumor remission
7 secondary outcomes
Adverse events (AE) and serious adverse events (SAE)
Time frame: Baseline to up to 28 days
ORR and CRR at the end of combination therapy
Time frame: Up to 1 year
Progression-free survival (PFS)
Time frame: Up to 2 years
Duration of response (DOR)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to all-cause death
1-year PFS and OS
Time frame: Up to 1 year
2-years PFS and OS
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQB3702 tablets+Chemotherapy regimen in people with B-cell Lymphoma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zengjun Li, Doctor (13642138692, zengjunli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.