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).

Start Date23 Apr 2025

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20250154

/ RecruitingPhase 1/2

TQB2825注射液联合免疫化疗在弥漫大B细胞淋巴瘤受试者中的Ib/II期临床试验

[Translation] Phase Ib/II clinical trial of TQB2825 injection combined with immunochemotherapy in subjects with diffuse large B-cell lymphoma

主要目的：评估TQB2825联合免疫化疗的剂量限制性毒性（DLT）、最大耐受剂量（MTD）和II期推荐剂量（RP2D）次要目的：通过评估ORR、CR率、PFS、DOR和OS等评估TQB2825联合免疫化疗在弥漫大B细胞淋巴瘤受试者中的初步有效性评价TQB2825联合免疫化疗在弥漫大B细胞淋巴瘤受试者中的安全性探索性目的：评价基因突变和ctDNA与其他指标的相关性。

[Translation]

Primary purpose: To evaluate the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of TQB2825 combined with immunochemotherapy Secondary purpose: To evaluate the preliminary efficacy of TQB2825 combined with immunochemotherapy in subjects with diffuse large B-cell lymphoma by evaluating ORR, CR rate, PFS, DOR and OS To evaluate the safety of TQB2825 combined with immunochemotherapy in subjects with diffuse large B-cell lymphoma Exploratory purpose: To evaluate the correlation between gene mutations and ctDNA and other indicators.

Start Date11 Apr 2025

Sponsor / Collaborator

Nanjing Shunxin Pharmaceutical Co., Ltd.

NCT06854445

/ RecruitingPhase 2

Phase II Clinical Trial of TQB2825 Injection Combined With Chemotherapy in Subjects With Relapsed/Refractory Diffuse Large B-cell Lymphoma

The purpose of this study is to assess the preliminary efficacy of TQB2825 in combination with chemotherapy in subjects with diffuse large B-cell lymphoma.

Start Date12 Mar 2025

Sponsor / Collaborator

Shanghai Zhengda Tianqing Pharmaceutical Co., Ltd.

100 Clinical Results associated with TQB-2825

100 Translational Medicine associated with TQB-2825

100 Patents (Medical) associated with TQB-2825

100 Deals associated with TQB-2825

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
ALK positive large B-cell lymphoma	Phase 2	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Apr 2025
Mediastinal large B-cell lymphoma	Phase 2	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Apr 2025
T-cell/histiocyte rich large B-cell lymphoma	Phase 2	China	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	23 Apr 2025
Diffuse large B-cell lymphoma recurrent	Phase 2	China	Shanghai Zhengda Tianqing Pharmaceutical Co., Ltd.	12 Mar 2025
Diffuse Large B-Cell Lymphoma	Phase 2	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	07 Mar 2025
CD20 positive Hematologic Neoplasms	Phase 1	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	10 Mar 2022
Follicular Lymphoma	IND Approval	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	26 Aug 2024
Mantle-Cell Lymphoma	IND Approval	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	26 Aug 2024
Marginal Zone B-Cell Lymphoma	IND Approval	China	Nanjing Shunxin Pharmaceutical Co., Ltd.	26 Aug 2024

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