[Translation] Phase I clinical trial of Denolan injection (or RC19D2 cell injection) for the treatment of CD19-positive relapsed or refractory diffuse large B-cell lymphoma

主要目的：评价RC19D2细胞注射液治疗CD19阳性的复发或难治性弥漫大B细胞淋巴瘤患者的安全性和耐受性；确定Ⅱ期临床试验的推荐给药剂量（RP2D）。次要目的：评价RC19D2细胞注射液治疗CD19阳性的复发或难治性弥漫大B细胞淋巴瘤的初步疗效；评价RC19D2细胞注射液在CD19阳性的复发或难治性弥漫大B细胞淋巴瘤患者中的细胞代谢动力学；评价RC19D2细胞注射液在CD19阳性的复发或难治性弥漫大B细胞淋巴瘤患者中的药效动力学；评价RC19D2细胞注射液的免疫原性。

[Translation]

Primary objectives: To evaluate the safety and tolerability of RC19D2 cell injection in the treatment of patients with CD19-positive relapsed or refractory diffuse large B-cell lymphoma; to determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: To evaluate the preliminary efficacy of RC19D2 cell injection in the treatment of CD19-positive relapsed or refractory diffuse large B-cell lymphoma; to evaluate the cell metabolic dynamics of RC19D2 cell injection in patients with CD19-positive relapsed or refractory diffuse large B-cell lymphoma; to evaluate the pharmacodynamics of RC19D2 cell injection in patients with CD19-positive relapsed or refractory diffuse large B-cell lymphoma; to evaluate the immunogenicity of RC19D2 cell injection.

Start Date31 Oct 2023

Sponsor / Collaborator

Beijing Yongtai Ruike Biotechnology Co. Ltd.

NCT06047197 / RecruitingPhase 1

Phase I Clinical Trial of Dinorencel Injection (or RC19D2 Cell Injection) in the Treatment of CD19-positive Relapsed or Refractory Diffuse Large B-cell Lymphoma

This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma

Start Date05 Sep 2023

Sponsor / Collaborator

Beijing Yongtai Ruike Biotechnology Co. Ltd.

NCT03720457 / Unknown statusPhase 1

A Phase I Clinical Trial of Human CD19 Targeted T Cells Injection for Subjects With Relapsed and Refractory CD19-positive Diffuse Large B-cell Lymphoma and Follicular Lymphoma

To evaluate the safety and tolerance of human CD19 targeted T Cells injection for the treatment of relapsed and refractory CD19-positive diffuse large B-cell lymphoma and follicular lymphoma. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19 CAR+ T cells.

Start Date13 Nov 2018

Sponsor / Collaborator

Hrain Biotechnology Co., Ltd.Startup

[+1]

100 Clinical Results associated with CD19 positive Diffuse Large B-Cell Lymphoma

100 Translational Medicine associated with CD19 positive Diffuse Large B-Cell Lymphoma

0 Patents (Medical) associated with CD19 positive Diffuse Large B-Cell Lymphoma

Literatures (Medical) associated with CD19 positive Diffuse Large B-Cell Lymphoma

01 Apr 2023·Asian Journal of Surgery

CD5-positive primary diffuse large B-cell lymphoma of the breast: A case report

Letter

Author: Ye, Miao ; Zhuang, Yongwei ; Song, Chengjun ; Zeng, Yuxiao

01 May 2020·Journal of International Medical ResearchQ4 · MEDICINE

CD56-positive diffuse large B-cell lymphoma/leukemia with BCL6/MYC double-hit and multiple gene mutations: an indicator of poor prognosis?

Q4 · MEDICINE

ReviewOA

Author: Shen, Jianzhen ; Liu, Tingbo ; Awal Issah, M. ; Liu, Yanquan ; Zhou, Huarong ; Fu, Haiying

Diffuse large B-cell lymphoma (DLBCL) is the most common adult non-Hodgkin lymphoma (NHL) and is highly invasive, with a poor prognosis. The main clinical treatment for DLBCL involves chemotherapy or a combination of chemotherapy and targeted drugs. CD56 expression is considered as an indicator of poor prognosis in patients with acute myeloid leukemia and anaplastic large cell lymphoma; however, its role in DLBCL remains unclear. We report on a patient with CD56-positive DLBCL/leukemia with BCL6/ MYC double-hit, and DDX3X, LRP1B, SIN3A, and GNA13 gene mutations (stage IVA, prognostic index aaIPI = 2 points). The patient was treated with cyclophosphamide and prednisone pre-chemotherapy plus R-Hyper-CVAD AB and DA-EPOCH regimens. Lumbar puncture combined with intrathecal injection was performed to prevent central nervous system infiltration during hospitalization, and complete remission was confirmed. We also reviewed the literature to clarify the relevance of the unique clinical features associated with this case.

08 Dec 2019·Zhonghua bing li xue za zhi = Chinese journal of pathology

[CD3-positive diffuse large B-cell lymphoma of fusiform cells in colon].

Article

Author: Zhou, X G ; Xie, J L ; Ma, D Y ; Zhang, Y L ; Zheng, Y Y

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CD19 positive Diffuse Large B-Cell Lymphoma

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