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Follicular LymphomaPhase 3NCT07187960

Evaluation of the Efficacy and Safety of TQB2825 Injection Compared to Immunotherapy in the Treatment of Recurrent/Refractory Follicular Lymphoma

A Phase 3 study testing TQB2825 Injection and Rituximab Injection in people with Follicular Lymphoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 28 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Evaluation of the efficacy and safety of TQB2825 injection compared to immunotherapy in the treatment of recurrent/refractory follicular lymphoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Follicular Lymphoma
What is being tested?
TQB2825 Injection and Rituximab Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
228 participants
Where
28 sitesChina
Study dates
Nov 2025to Feb 2029
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily join this study, sign the informed consent form (ICF), and have good compliance.
  • 18 years old ≤ age<80 years old (calculated based on the date of signing the informed consent form); No gender restrictions; Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-2.
  • Expected survival is greater than 6 months.
  • Follicular lymphoma (histological grade 1-3a) that meets the 2016 WHO diagnostic criteria or classic follicular lymphoma that meets the 2022 World Health Organization (WHO) diagnostic criteria, and immunophenotyping analysis shows CD20 positivity in the tumor.
  • Relapsed/refractory diseases that have received at least 2 lines of systemic treatment (at least 1 line containing CD20 monoclonal antibody) in the past, and have progressed during the most recent treatment period or relapsed after completing treatment, or have been confirmed to have no objective remission after sufficient treatment.
  • According to the 2014 Lugano criteria, there is at least one measurable lesion, which is a lymph node lesion with a length diameter greater than 15 mm or an extranodal lesion with a length diameter greater than 10 mm based on CT cross-sectional imaging.
  • The organ function is good.
  • Women of childbearing age should agree to use effective contraception during the study period and for 12 months after the end of study treatment, and agree not to donate eggs (oocytes) for reproductive purposes during this period; Not allowed to be in lactation period and have a negative serum or urine pregnancy test within 7 days before enrollment; Male patients who have not undergone vasectomy and their fertile female partners should agree to use effective contraceptive measures during the study period until 12 months after the end of the study treatment, and agree not to donate sperm during this period.

Who cannot join

  • Have had or currently have other malignant tumors within the previous 5 years of randomization. The following two situations can be included in the group: other malignant tumors that have been cured by a single surgery and have achieved continuous disease-free survival (DFS) for 5 years; Cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)].
  • Lymphoma has previously or currently affected or is suspected to affect the central nervous system, or there is evidence of lymphoma leukemia present.
  • There is evidence of transformation into diffuse large B-cell lymphoma or other types of lymphoma (such as biopsy showing large cells or Positron Emission Tomography (PET) showing significant abnormal high metabolism in one/some lymph nodes).
  • Active hepatitis or decompensated cirrhosis (Child Pugh liver function rating B or C). (Note: active hepatitis B refers to positive HBsAg, and Hepatitis B Virus (HBV) DNA is positive or the test value exceeds the upper limit of normal value; Active hepatitis C refers to Hepatitis B Virus (HCV) antibody positivity, and HCV RNA positivity or detection value exceeding the upper limit of normal; The eligible subjects with positive hepatitis B HBsAg but HBV DNA not exceeding the upper limit of normal value, whether their HBV DNA is measurable or not, need to continue antiviral treatment (nucleoside analogues are recommended) and regularly monitor HBV DNA; For subjects with positive hepatitis B HBcAb but negative HBsAg, HBV DNA needs to be monitored regularly, and preventive antiviral treatment is recommended; For subjects who are positive for hepatitis C HCV antibodies but whose HCV RNA does not exceed the upper limit of normal values, regular monitoring of HCV RNA is required.
  • The adverse reactions of previous treatments have not recovered to CTCAE 5.0 standard ≤ grade 1, except for grade 2 hair loss, non clinically significant and asymptomatic abnormal laboratory test values, stable hypothyroidism treated with hormone replacement therapy, and other adverse reactions that have been determined by researchers to have no safety risks.
  • Individuals who have undergone major surgical treatment, significant traumatic injury, or expected major surgery during the study treatment period within the first 4 weeks of randomization, or have long-term untreated wounds or fractures. (Note: Major surgery is defined as surgery at level 3 or above in the National Surgical Classification Catalogue 2022 edition)
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  • Within the first 4 weeks of randomization, any severe (≥ CTCAE grade 3) bleeding or bleeding events occurred.
  • Uncontrolled pleural effusion and ascites with clinical significance that require repeated drainage, as well as moderate or greater amounts of pericardial effusion.
  • Individuals who have experienced arterial/venous thrombotic events within the first 6 months of randomization, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, pulmonary embolism, or any other history of severe thromboembolism (implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis is not considered "severe" thromboembolism).
  • Suffering from significant cardiovascular disease.
  • Brain or mental abnormalities.
  • lung disease.
  • Active or uncontrolled infections.
  • Unexplained fever>38.5 ℃ occurred during the screening period or before the first medication.
  • Patients with renal failure who require hemodialysis or peritoneal dialysis and have a history of nephrotic syndrome.
  • History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases.
  • Patients with hypothyroidism and type 1 diabetes who are suffering from autoimmune diseases that need systemic treatment or who have received stable alternative treatment can be selected.
  • Preparing for or having previously received organ transplantation, or having a significant host transplant response, or having previously received allogeneic hematopoietic stem cell transplantation.
  • Systemic immunosuppressive therapy is required, including but not limited to: using cyclosporine, tacrolimus, etc. within the first 4 weeks of randomization, receiving high-dose glucocorticoid therapy (prednisone>30 mg/day or equivalent dose of other glucocorticoids), or receiving any other immunosuppressive therapy; Those who receive inhaled or topical corticosteroid treatment, or those who maintain a stable dose of prednisone<10 mg/day or equivalent doses of other corticosteroid systems for at least 4 weeks prior to the first administration, or those who receive steroid controlled lymphoma symptoms or prophylactic medication to prevent infusion reactions prior to the administration of the investigational drug, may be selected.
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
  • Previous history of anti-tumor treatment.
  • Known to be allergic to research drug excipient components.
  • Participated in and used other anti-tumor clinical trial drugs within the first 4 weeks or 5 half lives of randomization.
  • According to the researcher's perspective, other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may increase the risks associated with participating in the study or interfere with the interpretation of the research results.
  • It is estimated that the patient's compliance in participating in this clinical study is insufficient.

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuqin Song, Doctor contact

18191965905

1296764477@qq.com

28 sites in 1 country

China28 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Yuqin Song, Doctor, 18191965905, 1296764477@qq.com

  • People's Hospital of Hunan Province

    Changsha, Hunan, 410005

    Can Liu, Doctor, 13787285260, 617170469@qq.com

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    Li Yang, Doctor, 18623578818, 2664486657@qq.com

  • The Second Hospital Of Dalian Medical University

    Dalian, Liaoning, 116000

    Xiuhua Sun, Master, 17709873631, 3038668@vip.sina.com

  • Sun Yet-Sen University Cancer Certer

    Guangzhou, Guangdong, 510700

    Qingqing Cai, Doctor, 13798101121, caiqq@sysucc.org.cn

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

    Jishi Wang, Doctor, 13639089646, wangjishi9646@163.com

  • Hainan General Hospital

    Haikou, Hainan, 570311

    Zhaoqian Huang, Bachelor, 13907645959, HZQ2050@YEAH.NET

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

    Qingyuan Zhang, Doctor, 13313612989, sy86298276@163.com

  • The First People's Hospital Of Yunnan Province

    Kunming, Yunnan, 650100

    Yajie Wang, Doctor, 13211630338, 694634285@qq.com

  • Yunan Cancer Hospital

    Kunming, Yunnan, 650118

    Xun Lai, Doctor, 13577096609, 1729112214@qq.com

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730030

    Qike Zhang, Bachelor, 13893347579, zqk05@163.com

  • Linyi City People Hospital

    Linyi, Shandong, 276000

    Haiyan Zhang, Master, 13869986288, 13869986288@sina.com

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Wuping Li, Doctor, 13870659916, 18907001021@163.com

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Lei Fan, Doctor, 13813976136, fanlei3014@126.com

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200023

    Li Wang, Doctor, 15214371575, wl11196@rjh.com

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

    Ping Li, Doctor, 13564181131, lilyforever76@126.com

  • Shengjing Hospital Of China Medical University

    Shenyang, Liaoning, 110134

    Wei Yang, Doctor, 18940251012, yangw@sj-hospital.org

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030000

    Liping Su, Doctor, 13835158122, slpsy2022@163.com

  • People's Hospital of Tianjin

    Tianjin, Tianjin Municipality, 300121

    Huaqing Wang, Doctor, 18622221223, huaqingw@163.com

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300308

    Yafei Wang, Doctor, 18622221250, Drwang2005@163.com

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 301636

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830000

    Yan Li, Master, 13639935315, liyan232917@139.com

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

    Huijing Wu, Doctor, 13986195042, wuhuijing8034@126.com

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Pengcheng He, Doctor, 18991232609, Hepc_gcp@163.com

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

    Junjie Ma, Master, 18660487687, mjjshj@sina.com

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750000

    Chunzhou Huang, Bachelor, 13995106782, wenxian201211@162.com

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Keshu Zhou, Doctor, 13674902391, dr_zkshu23810@163.com

  • The First Affiliated Hospital Of Zhengzhou University

    Zhengzhou, Henan, 450000

    Xudong Zhang, Doctor, 13633825183, feeverxxd@126.com

Other trials in China

About this study

Official title: Randomized, Open Label, Multicenter Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2825 Injection Compared to Immunotherapy in the Treatment of Relapsed/Refractory Follicular Lymphoma

Evaluation of the efficacy and safety of TQB2825 injection compared to immunotherapy in the treatment of recurrent/refractory follicular lymphoma.

Being tested
TQB2825 Injection, Rituximab Injection
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2825 InjectionDrug

    TQB2825 is a Cluster of Differentiation 3 (CD3) × Cluster of Differentiation 20 (CD20) bispecific antibody.

  • Rituximab InjectionDrug

    Rituximab combined with Chemotherapy (Rituximab, Cyclophosphamide, doxorubicin, Vincristine, Prednisone, Ifosfamide, Gemcitabine, cisplatin, Carboplatin, Etoposide, MESNA, Dexamethasone)

Study groups in NCT07187960
Study groupRoleWhat they receive
TQB2825 InjectionExperimentalTQB2825 single drug intravenous injection, 28 days as a treatment cycle.
Receives: Drug: TQB2825 Injection
Rituximab InjectionActive comparatorRituximab combined with Chemotherapy regimen, 21 days as a treatment cycle.
Receives: Drug: Rituximab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS) evaluated by an independent review committee (IRC)

    Progression free survival (PFS) evaluated by an independent review committee (IRC)

    Measured: 2 years

Secondary outcomes (10)

  1. Objective response rate (ORR)

    The percentage of complete (CR) or partial response (PR) subjects determined by IRC based on the 2014 Lugano criteria or by researchers based on the 2014 Lugano criteria and LYRIC, respectively

    Measured: 2 years

  2. Complete response rate (CR rate)

    The percentage of complete (CR) subjects determined by IRC based on the 2014 Lugano criteria or by researchers based on the 2014 Lugano criteria and LYRIC, respectively.

    Measured: 2 years

  3. Progression free survival (PFS) evaluated by researchers

    The time from randomization to researcher evaluation of disease progression or death from any cause (whichever occurs first) is determined according to the 2014 Lugano criteria and LYRIC.

    Measured: 2 years

  4. Time to relief (TTR)

    The time from randomization to first remission assessed by IRC or researchers.

    Measured: 2 years

  5. Patient Outcome Report (PRO)

    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) scale.

    Measured: 2 years

  6. Second progression free survival (PFS2) evaluated by researchers

    The time for the first assessment of disease progression or death from any cause (whichever occurs first) by the investigator after receiving transfer treatment or treatment allowed by the protocol, from randomization to the first IRC confirmation of disease progression, shall be determined according to the 2014 Lugano criteria and LYRIC, respectively.

    Measured: 2 years

  7. The incidence and severity of adverse events (AEs)

    The incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs).

    Measured: 2 years

  8. Anti-Drug Antibodies (ADA) positivity rates

    ADA positivity rates

    Measured: 2 years

  9. Nab positivity rates

    Nab positivity rates

    Measured: 2 years

  10. Concentration of TBQ2825 in plasma

    Concentration of TBQ2825 in plasma

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2025
  2. Study startNov 2025 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
228 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07187960
Sponsor's protocol ID
TQB2825-III-01
Status last verified
Mar 2025
First submitted
17 Sep 2025
Last updated
23 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB2825 Injection and Rituximab Injection in people with Follicular Lymphoma, run by Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd. at 28 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 8 inclusion and 25 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: opening soon, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Yuqin Song, Doctor (18191965905, 1296764477@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) evaluated by an independent review committee (IRC) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07187960.

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 23 Sep 2025.

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