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

NCT07187960 | Not Yet Recruiting Phase 3

• 1 other identifier: TQB2825-III-01
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 28

Brief Summary

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

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

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

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

  2 years

Secondary Outcomes (10)

• Objective response rate (ORR)

  2 years

• Complete response rate (CR rate)

  2 years

• Progression free survival (PFS) evaluated by researchers

  2 years

• Time to relief (TTR)

  2 years

• Patient Outcome Report (PRO)

  2 years

Study Arms (2)

TQB2825 Injection

EXPERIMENTAL

TQB2825 single drug intravenous injection, 28 days as a treatment cycle.

Drug: TQB2825 Injection

Rituximab Injection

ACTIVE COMPARATOR

Rituximab combined with Chemotherapy regimen, 21 days as a treatment cycle.

Drug: Rituximab Injection

Interventions

TQB2825 Injection DRUG

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

TQB2825 Injection

Rituximab Injection DRUG

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

Rituximab Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily join this study, sign the informed consent form (ICF), and have good compliance.
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

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

Study Sites (28)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Gansu Provincial Hospital

Lanzhou, Gansu, 730030, China

Location

Sun Yet-Sen University Cancer Certer

Guangzhou, Guangdong, 510700, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital Of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

People's Hospital of Hunan Province

Changsha, Hunan, 410005, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

The Second Hospital Of Dalian Medical University

Dalian, Liaoning, 116000, China

Location

Shengjing Hospital Of China Medical University

Shenyang, Liaoning, 110134, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750000, China

Location

Linyi City People Hospital

Linyi, Shandong, 276000, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200023, China

Location

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030000, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

People's Hospital of Tianjin

Tianjin, Tianjin Municipality, 300121, China

Location

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300308, China

Location

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

Tianjin, Tianjin Municipality, 301636, China

Location

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, 830000, China

Location

The First People's Hospital Of Yunnan Province

Kunming, Yunnan, 650100, China

Location

Yunan Cancer Hospital

Kunming, Yunnan, 650118, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yuqin Song, Doctor

CONTACT

18191965905; 1296764477@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 23, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: September 23, 2025

Record last verified: 2025-03

Locations

CN (28)