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正在招募I 期 / II 期编号 NCT06829771

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

报名条件(概要)

  • 年龄:18 Years – 80 Years
  • 性别:不限
  • 健康志愿者:不接受

完整入排标准请以官方页面为准。

开展国家/地区

China

药品与企业信息

TQB2825 injection +R-CHOP regimen药物

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: 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.

研发企业

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.企业

试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。

研究简介(原文)

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).

适应症

Diffuse Large B Cell Lymphoma

主动联系研究团队

总联系人(申办方/研究总部)

中国/港澳台研究中心

问自己是否符合条件、如何预筛

我的病情档案

管理档案

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英文版(发给研究团队)

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma
ClinicalTrials.gov Identifier: NCT06829771
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Investigational product: TQB2825 injection +R-CHOP regimen, TQB2825 injection + GemOx

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照(供您核对)

尊敬的研究团队:

我是一位来自中国的患者,希望咨询参加以下临床试验的可能:

研究名称:Clinical Trial of TQB2825 Injection Combined Immunochemotherapy in Subjects With Diffuse Large B Cell Lymphoma
试验编号:NCT06829771
申办方:Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
研究药物:TQB2825 injection +R-CHOP regimen、TQB2825 injection + GemOx

我的基本情况:
- 年龄:(请填写)
- 性别:(请填写)
- 确诊疾病与分期:(请填写)
- 基因/标志物检测:暂无
- 既往及当前治疗:(请填写)
- 体能状态(ECOG):未评估
- 目前所在城市:中国
- 可前往范围:(请填写)

想请教三个问题:
1. 我是否可能符合本研究的入组标准?
2. 哪个中心对我最方便可行?能否远程预筛?
3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)?

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
(您的姓名)
(您的邮箱/带国际区号的电话)
用邮件客户端发送给 SongYQ_VIP@163.com

提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。

下一步怎么做?

  1. 把本页信息带给您的主治医生,评估是否适合参加。
  2. 点击下方按钮打开官方注册页,查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。
在 ClinicalTrials.gov 查看官方页面