A Cross-sectional Study on the Efficacy and Safety of the Combination of Daratumumab+Bortezomib+Dexamethasone Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease

It is expected to include 40 patients with M-protein related cardiac disease. The treatment medication for enrolled patients must comply with the treatment regimen of Daratumumab + Bortezomib + Dexamethasone. All patients were given Dapagliflozin 10mg/day at the beginning of treatment (creatinine clearance rate greater than 20ml/min).

开始日期2024-03-15

申办/合作机构

Beijing Chao-Yang Hospital

[+1]

NCT05675943 / RecruitingN/AIIT

A Multicenter, Randomized, Single-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy and Safety of the Anti-COVID-19 Antibody SA55 for Injection in the Treatment of Patients With Hematological Disorders Who Are Persistently Positive for the Covid-19

This study is a multicenter, randomized, single-blind, placebo-controlled clinical trial to evaluate the effectiveness and safety of Anti-COVID-19 Antibody SA55 for Injection in patients with hematological malignancies. This study consists of two stages. In the first stage, 8 subjects aged 18-75 were recruited for safety assessment, including the monitoring of clinical test indicators and adverse events. After confirming the preliminary safety results of the first stage, we plan to recruit 160 COVID-19 patients with hematologic disorders aged 1-75 years old and randomly divided into the SA55 group and the placebo group with a ratio of 3:1. Basic information and laboratory tests will be collected during the whole study, and the occurrence of adverse events and SAEs of all subjects were collected.

开始日期2023-01-09

申办/合作机构

Beijing Boren Hospital

100 项与 Beijing Boren Hospital 相关的临床结果

登录后查看更多信息

0 项与 Beijing Boren Hospital 相关的专利（医药）

登录后查看更多信息

101

项与 Beijing Boren Hospital 相关的文献（医药）

2024-08-01·Clinical Nuclear Medicine

Splenic Pseudoprogression After CAR-T Therapy Detected by 18F-FDG PET/CT in a Refractory Diffuse Large B-Cell Lymphoma Patient

Article

作者: Kan, Ying ; Wang, Hongrong ; Yao, Xilan ; Yang, Jigang ; Wang, Wei

AbstractA 43-year-old woman diagnosed with refractory diffuse large B-cell lymphoma was referred to chimeric antigen receptor T-cell therapy at our institution. After 3 cycles of bridging therapy, preinfusion 18F-FDG PET/CT suggested a complete metabolic response. 18F-FDG PET/CT 1 month after chimeric antigen receptor T-cell infusion showed 2 foci of elevated activity in the spleen, which was finally confirmed as pseudoprogression.

2024-06-01·Journal of Clinical Oncology

Phase I study of functionally enhanced CD33 CAR T cells in patients with relapsed or refractory acute myeloid leukemia.

作者: Duan, Jiajia ; Pan, Jing ; Feng, Xiaoming ; Ling, Zhuojun ; Xu, Jinlong ; Li, Chuo ; Wu, Tong ; Zuo, Shiyu ; Wang, Zelin

6518 Background: Chimeric antigen receptor (CAR) T-cell therapy has shown promising efficacy in B-cell malignancies (Majzner RG, et al. Nat Med. 2019 Sep;25(9):1341-1355). However, its feasibility in acute myeloid leukemia (AML) is not fully established. CD33 CAR T-cell therapy in relapsed or refractory (r/r) AML have reported limited or no significant anti-leukemic effects (Tambaro FP, et al. Leukemia. 2021 Nov;35(11):3282-3286; Wang QS, et al. Mol Ther. 2015 Jan;23(1):184-91). CD123 CAR T-cell therapy has weak proliferation and low CR rates (Wermke M, et al. Blood. 2021 Jun 3;137(22):3145-3148; Cummins, Katherine D. et al. Blood. 2017; 130: 1359), while CLL1 CAR T-cell therapy has induced anti-leukemic responses in a small subset of patients without sustained expansion (Pei K, et al. Cancer Med. 2023 Apr;12(8):9655-9661; Jin X, et al. J Hematol Oncol. 2022 Jul 7;15(1):88). Here, we present early safety and efficacy of functionally enhanced CD33 CAR T cells in AML. Methods: We improved the performance of CD33 CAR T cells by adding a potentiating molecule linked to human CD33 scFv by P2A. The study was registered with ClinicalTrials.gov (NCT04835519). The trial used the “3+3” approach, starting with an initial dose of 5×105 (±20%)/kg. The primary endpoint was safety with efficacy secondary. Results: Four relapsed patients, including three who underwent stem cell transplantation, were enrolled and received initial dose of CAR T cells between April 13, and July 28, 2021. The Data and Safety Monitoring Committee approved the preliminary report. Three patients (75%) experienced grade 1−2 cytokine release syndrome (CRS), while one (25%) had grade 4 CRS. One developed grade 2 CRS after the second infusion. One patient had dose-limiting toxicity. Two patients (50%) had grade 1 neurotoxicity, and two (50%) developed grade 1–2 graft-versus-host disease. All patients experienced grade 2–4 neutropenia, monocytopenia, and thrombocytopenia. One patient developed sepsis. Two patients achieved CR with incomplete hematologic recovery (CRi) and were MRD-negative at day 30, while two had no response. Of these, one patient received a second infusion and achieved MRD+ CRi. Two patients have remained disease free for over two years. One patient remained disease free for one year before CD33+ relapse. The two patients with CRi had peak CAR T cell counts of 192 and 23.5 cells/μl, while the two without CRi had lower peak counts of 2.12 and 10.3 cells/μl. One patient peaked at 1.73 cells/μl after the second infusion. The two patients with CRi also had a higher proportion of CAR T cells among the lymphocytes (46.8% and 53.0%). As expected, peripheral blood CD33+ cells decreased. Conclusions: We report the safety and efficacy of functionally enhanced CD33 CAR T cells. While some patients had CRi, there was also depletion of CD33-positive normal cells. Thus, further research is needed to address the issue of normal cell depletion. Clinical trial information: NCT04835519 .

2024-04-05·Cancer Research

Abstract CT244: HR001, a novel CD19-targeted CAR-T cell therapy for patients with relapsed/refractory non-Hodgkin's lymphoma: primary results of a phase II study (HRAIN01-NHL01-II)

作者: Deng, Qi ; Song, Xianmin ; Li, Wuping ; Li, Xin ; Cao, Jiang ; Hu, Kai ; Jing, Hongmei ; Zhang, Yian ; Chen, Bing ; Li, Yuhua ; Ge, Zheng ; Wang, Qingming ; Liu, Peng ; Xue, Hongwei ; Zhai, Zhimin ; Shen, Jianping ; Geng, Liangquan ; Yu, Kang

AbstractBackground: HR001 is a CD19-targeted CAR-T cell for patients with relapsed and refractory non-Hodgkin's (R/R NHL). Here, we report the primary results of the phase 2 study (HRAIN01-NHL01-II).Methods: HRAIN01-NHL01-II is an open-label, single-arm, and multicenter (17 centers) study in China. It enrolled R/R NHL patients treated with at least two lines of therapy (must-have anthracycline and CD20-targeted agents) or after autologous hematopoietic stem cell transplantation. All patients received a single infusion of HR001 at the 2.0 × 106 CAR+T cells/kg dose. The disease response was evaluated by the independent review committee with Lugano response criteria [2014].Results: As of May 16th, 2023, 81 R/R NHL patients with ECOG 0-1 at baseline received the infusion HR001 from the Jinshan manufacturing facility [51.9% male; median age 53.4 years (range 23~74); 3.7% CD19 negative; 91.4% diffuse large B-cell lymphoma; 79.0% III-IV of Ann Arbor classification or Lugano] with a median follow-up of 160 days (range 7 to 454). The median time to best response was 30 days (range 28-358). The 3-month, 6 month and best objective response rate (ORR) was 53.1%(95% CI: 41.7-64.3), 45.7%(95% CI: 34.6-57.1) and 74.1% (95% CI: 63.1-83.2) respectively. The 3-month, 6 month and best complete response rate (CRR) was 32.1%(95% CI: 22.2-43.4), 29.6%(95% CI: 20.0-40.8) and 49.4%(95% CI: 38.1-60.7) respectively. Median duration of response (DOR) and progression-free survival (PFS) were 339 days (95% CI: 149-NE) and 176 days (95% CI: 91-NE) respectively. The overall survival (OS) was not reached. The most common treatment-related adverse events (AEs) happened in the hematologic system. The cytokine release syndrome (CRS) occurred in 95.1% of patients, with ≥3 grade CRS observed in 3.7% of patients. Immune effector cell-associated neurotoxicity syndrome (ICANS) happened in 8.6% of patients, without any ≥ 3 grade ICANS reported. The treatment-related mortality was 1.2%. The median time to CAR T-cell peak expansion was 240 hours (120~672) after infusion, median maximum expansion (Cmax) was 17413.9 copies/μg DNA (124.9~136382.2), and median AUC0-28d was 3201014.0 copies/μg DNA (205082.8~18400016.2). Positive tests for the anti-drug antibody (ADA) were noted in 14.8% of patients, while neutralizing antibody (Nab) tests were positive in 3.7% of patients. Among Nab-positive patients, the complete response was maintained until follow-up.Conclusions: Patients with R/R NHL could benefit from the HR001 treatment with satisfactory objective response, durable remission, and favorable safety profile.Citation Format: Yian Zhang, Yuhua Li, Kai Hu, Wuping Li, Hongwei Xue, Qi Deng, Zheng Ge, Liangquan Geng, Xianmin Song, Kang Yu, Hongmei Jing, Bing Chen, Xin Li, Zhimin Zhai, Jianping Shen, Jiang Cao, Qingming Wang, Peng Liu. HR001, a novel CD19-targeted CAR-T cell therapy for patients with relapsed/refractory non-Hodgkin's lymphoma: primary results of a phase II study (HRAIN01-NHL01-II) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr CT244.

100 项与 Beijing Boren Hospital 相关的药物交易

登录后查看更多信息

100 项与 Beijing Boren Hospital 相关的转化医学

登录后查看更多信息

组织架构

使用我们的机构树数据加速您的研究。

或

查看完整样例数据

管线布局

2024年12月22日管线快照

管线布局中药物为当前组织机构及其子机构作为药物机构进行统计，早期临床1期并入临床1期，临床1/2期并入临床2期，临床2/3期并入临床3期

临床1期

临床2期

其他

登录后查看更多信息

当前项目

药物(靶点)	适应症	全球最高研发状态

Anti CD22 chimeric antigen receptor T cell therapy(Shanghai YaKe Biotechnology Co Ltd) ( CD22 )	急性淋巴细胞白血病更多	临床2期
Autologous CD7-CAR T Cells(Beijing Boren Hospital) ( CD7 )	难治性T淋巴细胞淋巴瘤更多	临床2期
CI-135 CAR-T cells(Beijing Boren Hospital)	复发性急性髓细胞白血病更多	临床1期
CD5 CAR T cells(Beijing Boren Hospital) ( CD5 )	T细胞急性淋巴细胞白血病/淋巴瘤更多	临床1期
CAR-NK-CD19 Cells(Beijing Boren Hospital) ( CD19 )	非霍奇金淋巴瘤更多	临床1期