Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma

NCT06829771 | Recruiting Phase 1

• 1 other identifier: TQB2825-Ib/II-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 25

Brief Summary

To explore the efficacy and safety of TQB2825 injection combined immunochemotherapy in subjects with untreated or R/R DLBCL. The efficacy evaluation indicators are objective response rate (ORR), complete response rate (CR rate),progression free survival (PFS), duration of response (DOR) and overall survival(OS). The safety evaluation indicators are dose-limiting toxicity (DLT) , maximum tolerated dose (MTD)and recommended phase II dose (RP2D).

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose Limited Toxicity

  The occurrence of one or more unacceptable toxicities after administration, which prevents the increase of dosage or the extension of the dosing interval.

  Baseline to up to two years

• Maximum tolerated dose (MTD)

  If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.

  Baseline to up to two years

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  Baseline to up to two years

• Complete response (CR)

  Baseline to up to two years

• Progression-free survival (PFS)

  Baseline to up to two years

• Duration of Remission (DOR)

  Baseline to up to two years

• Overall survival (OS)

  Baseline to up to five years

Study Arms (2)

TQB2825 injection +R-CHOP

EXPERIMENTAL

TQB2825 injection+R-CHOP (Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone) TQB2825 injection,Rituximab,Cyclophosphamide,DoxorubicinHydrochloride,Vincristine,Prednisone,21 days as a treatment cycle.

Drug: TQB2825 injection +R-CHOP regimen

TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin)

EXPERIMENTAL

TQB2825 injection, Gemcitabine, Oxaliplatin, 21 days as a treatment cycle.

Drug: TQB2825 injection + GemOx

Interventions

TQB2825 injection +R-CHOP regimen DRUG

R-CHOP is a cancer treatment regimen that uses a combination of five drugs to treat non-Hodgkin lymphoma, e.g., Rituximab+Cyclophosphamide+Doxorubicin Hydrochloride+Vincristine+Prednisone (R-CHOP). TQB2825 Injection: TQB2825 is a bispecific antibody targeting the cluster of differentiation 20 (CD20) receptor on tumor cells and the cluster of differentiation 3 (CD3) receptor on T cells. Rituximab: A monoclonal antibody that binds to the CD20 antigen on the surface of B cells. Cyclophosphamide: An alkylating agent that inhibits the synthesis of DNA and proteins in cancer cells. Doxorubicin Hydrochloride: An antineoplastic antibiotic that inhibits the synthesis of DNA and RNA. Vincristine: A microtubule inhibitor that blocks the normal function of microtubules during cell division. Prednisone: A corticosteroid drug with anti-inflammatory, anti-allergic, immunosuppressive, and anti-cancer effects. TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin)

TQB2825 injection +R-CHOP

TQB2825 injection + GemOx DRUG

TQB2825 Injection: TQB2825 is a bispecific antibody targeting the CD20 receptor on tumor cells and the CD3 receptor on T cells. Gemcitabine: A nucleoside analog that inhibits DNA synthesis. Oxaliplatin: A platinum-based chemotherapy drug that forms cross-links with DNA, inhibiting DNA replication and transcription.

TQB2825 injection + GemOx (Gemcitabine + Oxaliplatin)

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily participate in this study, sign the informed consent form, and have good compliance;
• Age 18 to under 80 years old (calculated from the date of signing the informed consent form);
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
• Life expectancy greater than 12 weeks;
• In the dose expansion phase, previously untreated patients with International Prognostic Index (IPI) scores of 2-5;
• A confirmed diagnosis of diffuse large B-cell lymphoma or grade 3b follicular lymphoma, in accordance with the 2022 World Health Organization (WHO) diagnostic criteria, based on histology or cytology (including diffuse large B-cell lymphoma-not otherwise specified and transformed from indolent lymphomas, not allowing for the following types or components: double-hit, triple-hit, or high-grade B-cell lymphoma-not otherwise specified, mediastinal large B-cell lymphoma, T/histiocyte-rich large B-cell lymphoma, human herpesvirus 8 (HHV8)-positive/primary effusion lymphoma, Anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma, Burkitt's lymphoma, and Hodgkin's lymphoma, etc.);
• Immunophenotypic analysis shows that the tumor is CD20 positive;
• Previous treatment meets the following criteria:
• Combined with R-CHOP patients: previously untreated diffuse large B-cell lymphoma patients, allowing for corticosteroid pre-treatment (with or without vincristine) or non-curative palliative local radiotherapy.
• Combined with GemOx patients: patients with diffuse large B-cell lymphoma who have received at least one line of systemic treatment (including at least one line with CD20 monoclonal antibody) and are not suitable for hematopoietic stem cell transplantation or have failed treatment after transplantation or relapsed, and whose disease progressed during the most recent treatment or relapsed after completion of treatment or confirmed no objective response after adequate treatment.
• According to the 2014 Lugano criteria, there is at least one measurable lesion, i.e., lymph node lesions with a long diameter \>15 mm or extranodal lesions with a long diameter \>10 mm based on CT cross-sectional imaging; Positron emission tomography (PET)-computed tomography (CT) scan shows PET positivity;
• Laboratory tests meet the following criteria (not corrected with blood transfusion or hematopoietic growth factors within 14 days before screening):
• Hemoglobin (HGB) ≥80g/L;
• Absolute neutrophil count (NEUT) ≥1.0×10∧9/L;
• Platelet count (PLT) ≥ 75×10∧9/L (if accompanied by bone marrow invasion, platelets ≥50×10∧9/L).

You may not qualify if:

• The subject has had or currently has other malignant tumors that occurred within 5 years before the first dose of the study drug. The following two situations are eligible for enrollment: other malignant tumors that have been treated with single surgery and have achieved continuous 5 years of disease-free survival (DFS); cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors \[Ta (non-invasive tumors), Tis (carcinoma in situ), and T1 (tumors infiltrating the basement membrane)\];
• Adverse reactions from previous treatments have not recovered to a Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score of ≤1, except for grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and hypothyroidism stabilized with hormone replacement therapy, which are deemed to have no safety risks by the investigator;
• Received major surgical treatment, significant traumatic injury within 4 weeks before the first dose, or expected to undergo major surgery during the study treatment period, or has long-term unhealed wounds or fractures;
• Any subject with bleeding or bleeding events ≥CTC AE grade 3 within 4 weeks before the first dose;
• A history of arterial/venous thrombotic events within 6 months before the first dose, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism, or any other history of serious thromboembolism (thrombosis from implanted venous access ports or catheters, or superficial vein thrombosis is not considered "serious" thromboembolism);
• Clinically significant uncontrollable pleural effusion requiring repeated drainage, ascites, moderate or greater pericardial effusion;
• Decompensated cirrhosis (Child-Pugh liver function rating of B or C) and active hepatitis (hepatitis B reference: positive HBsAg, and positive hepatitis B virus (HBV) DNA or detection value exceeding the lower limit of detection; hepatitis C reference: positive HCV antibody, and positive hepatitis C virus (HCV) RNA or detection value exceeding the lower limit of detection); Note: Subjects with hepatitis B who are positive for HBsAg, regardless of whether their HBV DNA is detectable, must continue antiviral treatment (nucleoside analogs recommended) and regularly monitor HBV DNA; for subjects with hepatitis B who are positive for HBcAb but negative for HBsAg, regular monitoring of HBV DNA is required, and prophylactic antiviral treatment is recommended; for hepatitis C subjects, regular monitoring of HCV RNA is required.
• Pulmonary diseases, including any of the following conditions:
• Past or present non-infectious pneumonia requiring treatment with corticosteroids (including but not limited to acute respiratory distress syndrome, acute hypersensitivity pneumonia, drug-related pneumonia, bronchospasm, acute interstitial pneumonia, idiopathic pulmonary interstitial fibrosis, etc.);
• Past or present chronic obstructive pulmonary disease (COPD), and forced expiratory volume in one second (FEV1) \<60% (predicted value);
• Brain or mental abnormalities, including any of the following conditions:
• A history of substance abuse that cannot be quit;
• Accompanying or past central nervous system disease history, including epileptic seizures, hemorrhagic/ischemic stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, paralysis, aphasia, mental illness, consciousness disturbance, unexplained coma, neuropathy, organic brain syndrome, etc.;
• Brain MRI evidence indicating inflammatory lesions and/or vasculitis;
• Cerebrovascular accidents, cerebral infarction, etc., within 6 months before the first dose;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (25)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

NOT YET RECRUITING

Maanshan People's Hospital

Ma’anshan, Anhui, 243000, China

RECRUITING

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, 362000, China

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

Liuzhou People's Hospital

Liuchow, Guangxi, 545006, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

Puyang Oilfield General Hospital

Puyang, Henan, 457001, China

NOT YET RECRUITING

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, 457000, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

NOT YET RECRUITING

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210000, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

NOT YET RECRUITING

Jiangxi Canser Hospital

Nanchang, Jiangxi, 330029, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

NOT YET RECRUITING

The second Hospital of dalian

Dalian, Liaoning, 116000, China

NOT YET RECRUITING

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 26400, China

NOT YET RECRUITING

Fudan university shanghai cancer center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shannxi, 710000, China

NOT YET RECRUITING

Shanxi Cancer hospital

Taiyuan, Shanxi, 30000, China

NOT YET RECRUITING

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

NOT YET RECRUITING

People's Hospital of Tianjin (City)

Tianjin, Tianjin Municipality, 300000, China

NOT YET RECRUITING

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yuqin Song, Doctor

CONTACT

13683398726; SongYQ_VIP@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 17, 2025
• Study Start: April 23, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (25)