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RecruitingNCT06566586Updated Nov 20, 2024

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 interventional study of TQB3702 tablets+Chemotherapy regimen in B-cell Lymphoma, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Recruiting at 30 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • B-cell Lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. Relapsed/refractory indolent B-cell lymphoma
    2. 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    TQB3702 tablets+Chemotherapy regimen

    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

    Drug: TQB3702 tablets+Chemotherapy regimen

Interventions

  • DrugTQB3702 tablets+Chemotherapy regimen

    TQB3702 tablets: Tyrosine kinase inhibitor; Chemotherapy regimen:inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis;

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 2 years

  2. Complete response rate (CRR)

    The rate of complete tumor remission

    Time frame: Up to 2 years

Secondary outcomes

  1. 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

    Time frame: Baseline to up to 28 days

  2. ORR and CRR at the end of combination therapy

    Objective response rate and complete remission rate at the end of combination therapy.

    Time frame: Up to 1 year

  3. Progression-free survival (PFS)

    PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.

    Time frame: Up to 2 years

  4. Duration of response (DOR)

    The period from the participants first achieving CR or PR to disease progression

    Time frame: Up to 2 years

  5. Overall survival (OS)

    OS is defined as the time from the first administration to all-cause death

    Time frame: Up to all-cause death

  6. 1-year PFS and OS

    1-year Progression-free survival and Overall survival rates

    Time frame: Up to 1 year

  7. 2-years PFS and OS

    2-years Progression-free survival and Overall survival rates

    Time frame: Up to 2 years

07

Study locations

1 of 30 sites recruiting
  • Cancer Hospital Chinise Academy of Medical Sciences
    BeiJing, Beijing 100021, China
    Not yet recruiting
  • Gansu Provincial Cancer Hospital
    Lanzhou, Gansu 730000, China
    Not yet recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, Guangdong 510000, China
    Not yet recruiting
  • Guigang City People's Hospital
    Guigang, Guangxi 537000, China
    Not yet recruiting
  • Guangxi Medical University Cancer Hospital
    Nanning, Guangxi 530021, China
    Not yet recruiting
  • Guangxi Medical University Cancer Hospital
    Nanning, Guangxi 530021, China
    Not yet recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang 150000, China
    Not yet recruiting
  • PuYang AnYang District Hospital
    Anyang, Henan 450000, China
    Not yet recruiting
  • Puyang People's Hospital
    Puyang, Henan 457000, China
    Not yet recruiting
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450000, China
    Not yet recruiting
  • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
    Zhengzhou, Henan 457000, China
    Not yet recruiting
  • Union Hosiptal, Tongji Medical College, Huazhong University of Science And Technolocy
    Wuhan, Hubei 430022, China
    Not yet recruiting
  • Tongji Hospital Tongji Medical College of HUST
    Wuhan, Hubei 430030, China
    Not yet recruiting
  • Xiangyang Central Hospital
    XiangYang, Hubei 441000, China
    Not yet recruiting
  • Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
    Changsha, Hunan 410013, China
    Not yet recruiting
  • Zhuzhou Central Hospital
    Zhuzhou, Hunan 412000, China
    Not yet recruiting
  • The Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia 10000, China
    Not yet recruiting
  • Jiangsu Provincial People's Hospital
    Nanjing, Jiangsu 210000, China
    Not yet recruiting
  • The First Affiliated Hospital of Nanchang University
    Nanchang, Jiangxi 330006, China
    Not yet recruiting
  • The second Hospital of dalian
    Dalian, Liaoning 116000, China
    Not yet recruiting
  • The Second Affiliated Hospital Of Xi'an Jiaotong University(Xibei Hospital)
    Xi'an, Shaanxi 710004, China
    Not yet recruiting
  • Affiliated Cancer Hospital of Shandong First Medical University
    Jinan, Shandong 250117, China
    Recruiting
  • Tai'an Central Hospital
    Tai'an, Shandong 271000, China
    Not yet recruiting
  • Tongji Hospital of Tongji University
    Shanghai, Shanghai 200063, China
    Not yet recruiting
  • Shanxi Cancer Hospital
    TaiYuan, Shanxi 030000, China
    Not yet recruiting
  • The Affiliated Hospital of Southwest Medical University
    Luzhou, Sichuan 646000, China
    Not yet recruiting
  • Zigong First People's Hospital
    Zigong, Sichuan 643000, China
    Not yet recruiting
  • Tianjin People's Hospital
    Tianjin, Tianjin 300122, China
    Not yet recruiting
  • Tianjin Medical University Cancer Institute and Hospital
    Tianjin, Tianjin 300202, China
    Not yet recruiting
  • Affiliated Tumor Hospital of Xinjiang Medical University
    Ürümqi, Xinjiang 830000, China
    Not yet recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06566586
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Aug 22, 2024
Start date
Nov 6, 2024
Primary completion
Mar 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 20, 2024

Study contacts

Zengjun Li, Doctor
Contact
zengjunli@163.com
13642138692
Fei Li, Doctor
Contact
yx021021@sina.com
13970038386

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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