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

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

NCT07187960•Shanghai Chia Tai Tianqing Pharmaceutical Technology Development Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily join this study, sign the informed consent form (ICF), and have good compliance.
•2. 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.
•3. Expected survival is greater than 6 months.
•4. 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.
•5. 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.
•6. 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.
•7. The organ function is good.
•8. 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.

Exclusion Criteria

•1. 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\].
•2. Lymphoma has previously or currently affected or is suspected to affect the central nervous system, or there is evidence of lymphoma leukemia present.
•3. 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).
•4. 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.
•5. 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.
•6. 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)
•7. Within the first 4 weeks of randomization, any severe (≥ CTCAE grade 3) bleeding or bleeding events occurred.
•8. Uncontrolled pleural effusion and ascites with clinical significance that require repeated drainage, as well as moderate or greater amounts of pericardial effusion.
•9. 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).
•10. Suffering from significant cardiovascular disease.
+15 more criteria

Locations (28)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

Sun Yet-Sen University Cancer Certer

Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Hainan General Hospital

Haikou, Hainan, China

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital Of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Key Dates

Start Date

November 1, 2025

Primary Completion Date

October 1, 2028

Completion Date

February 1, 2029

Last Updated

September 23, 2025

Enrollment

228

ESTIMATED participants

Conditions

Follicular Lymphoma

Interventions

TQB2825 Injection

DRUG

Rituximab Injection

DRUG

Contacts

Yuqin Song, Doctor

CONTACT

18191965905 1296764477@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 23, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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