RecruitingPhase 1Phase 2NCT06829771

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

Phase Ib/II Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

90 participants

Start Date

Apr 23, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing TQB2825 — a bispecific antibody that helps the immune system target cancer cells — combined with standard chemotherapy and rituximab (a drug that targets B-cell lymphoma) for people with newly diagnosed diffuse large B-cell lymphoma (DLBCL), an aggressive type of blood cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have newly diagnosed DLBCL or grade 3b follicular lymphoma confirmed by biopsy (per WHO 2022 criteria) - You have not received prior treatment for this lymphoma - You have a moderate to high disease risk score (IPI score of 2–5) during the expansion phase - You have at least one measurable tumor on a scan - Your expected survival is at least 12 weeks - You are in good health (ECOG score 0–2) **You may NOT be eligible if...** - You have received prior treatment for this lymphoma - You have active brain lymphoma or CNS involvement - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2825 injection +R-CHOP regimen

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)

DRUGTQB2825 injection + GemOx

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.

Locations(25)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Maanshan People's Hospital

Ma’anshan, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Liuzhou People's Hospital

Liuzhou, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Puyang Oilfield General Hospital

Puyang, Henan, China

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Jiangxi Canser Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The second Hospital of dalian

Dalian, Liaoning, China

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Fudan university shanghai cancer center

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shannxi, China

Shanxi Cancer hospital

Taiyuan, Shanxi, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

People's Hospital of Tianjin (City)

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Hospital

Tianjin, Tianjin Municipality, China

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