CD5 CAR T cells(Beijing Boren Hospital)(CD5 CAR T cells(Beijing Boren Hospital)) - 药物靶点：CD5_在研适应症：T细胞急性淋巴细胞白血病/淋巴瘤，难治性 T 急性淋巴细胞白血病_专利_临床

概要

基本信息

药物类型

通用型CAR-T

别名

靶点

CD5

作用机制

T细胞表面糖蛋白CD5抑制剂

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症

T细胞急性淋巴细胞白血病/淋巴瘤难治性 T 急性淋巴细胞白血病

非在研适应症-

原研机构

Beijing Boren Hospital

在研机构

Beijing Boren Hospital

非在研机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)临床1期

特殊审评-

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关联

3

项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的临床试验

NCT05487495 / Recruiting临床1期IIT

First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T (CT125B) Cells forRelapsed or Refractory T-Cell Acute Lymphoblastic Leukemia/Lymphoma

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T (CT125B) cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma. 9-18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.

开始日期2022-07-27

申办/合作机构

Beijing Boren Hospital

NCT05032599 / Recruiting临床1期IIT

First-in-Human (FIH), Open-Label, Non-Randomized, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T Cells in Subjects With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia

This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10^6 (±20%) to dose 2: 2×10^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10^5 (±20%) /kg.

开始日期2021-09-14

申办/合作机构

Beijing Boren Hospital

ChiCTR2000039519 / Recruiting早期临床1期IIT

A single-center, open, non-randomized, single-arm clinical trial of donor CD5-CAR T cells in the treatment of refractory/relapsed acute T lymphoblastic leukemia in children

开始日期2020-10-29

申办/合作机构

Beijing Boren Hospital

100 项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的临床结果

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100 项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的转化医学

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100 项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的专利（医药）

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12

项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的文献（医药）

2024-03-28·Blood

Antitumor efficacy and safety of unedited autologous CD5.CAR T cells in relapsed/refractory mature T-cell lymphomas

Article

作者: Mehta, Birju ; Hill, LaQuisa C. ; Ma, Royce ; Wang, Tao ; Wu, Mengfen J. ; Burkhardt, Phillip M. ; Rouce, Rayne H. ; Grilley, Bambi ; Arredondo, Martha ; Zhang, Huimin ; Lulla, Premal ; Heslop, Helen E. ; Mamonkin, Maksim ; Lapteva, Natalia ; Ramos, Carlos A. ; Yang, Lina ; Smith, Tyler S. ; Brenner, Malcolm K. ; Srinivasan, Madhuwanti ; Mei, Zhuyong

AbstractDespite newer targeted therapies, patients with primary refractory or relapsed (r/r) T-cell lymphoma have a poor prognosis. The development of chimeric antigen receptor (CAR) T-cell platforms to treat T-cell malignancies often requires additional gene modifications to overcome fratricide because of shared T-cell antigens on normal and malignant T cells. We developed a CD5-directed CAR that produces minimal fratricide by downmodulating CD5 protein levels in transduced T cells while retaining strong cytotoxicity against CD5+ malignant cells. In our first-in-human phase 1 study (NCT0308190), second-generation autologous CD5.CAR T cells were manufactured from patients with r/r T-cell malignancies. Here, we report safety and efficacy data from a cohort of patients with mature T-cell lymphoma (TCL). Among the 17 patients with TCL enrolled, CD5 CAR T cells were successfully manufactured for 13 out of 14 attempted lines (93%) and administered to 9 (69%) patients. The overall response rate (complete remission or partial response) was 44%, with complete responses observed in 2 patients. The most common grade 3 or higher adverse events were cytopenias. No grade 3 or higher cytokine release syndrome or neurologic events occurred. Two patients died during the immediate toxicity evaluation period due to rapidly progressive disease. These results demonstrated that CD5.CAR T cells are safe and can induce clinical responses in patients with r/r CD5-expressing TCLs without eliminating endogenous T cells or increasing infectious complications. More patients and longer follow-up are needed for validation. This trial was registered at www.clinicaltrials.gov as #NCT0308190.

2020-01-01·Clinical Nephrology4区 · 医学

Correlation of IL-6 secretion and hyponatremia with the use of CD19+ chimeric antigen receptor T-cells

4区 · 医学

Article

作者: Latcha, Sheron ; Dixon, Brianne N. ; Brentjens, Renier J. ; Park, Jae H. ; Purdon, Terence J. ; Buie, Larry W. ; Daley, Ryan J. ; Hsu, Meier

BACKGROUNDVarious studies have demonstrated that interleukin-6 (IL-6) activates the central magnocellular arginine vasopressin (AVP)-secreting neurons in the brain to produce non-osmotic, non-volume-mediated increases in AVP. The most common toxicity of CD19+ chimeric antigen receptor (CAR) T-cells is cytokine release syndrome, which is related to increased levels of IL-6. This study will evaluate the correlation of IL-6 levels with hyponatremia in patients receiving CD19+ CAR T-cells.MATERIALS AND METHODSThis is a single-center retrospective analysis of adult patients who received CD19+ CAR T-cells for the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL).RESULTSHyponatremia, defined as a serum sodium (Na) ≤ 135 mEq/L, occurred in 31 (61%) patients. A change in Na > 7 mEq occurred in 32 (63%) patients, and the median lowest Na was 133 mEq/L (interquartile range (IQR): 131 - 136)). There was an inverse linear relationship between IL-6 levels and lowest Na (p = 0.001). Overall, per 10-fold increase in IL-6, Na decreased by an average of 2.68 mEq/L.CONCLUSIONHyponatremia is common in patients who received CD19+ CAR T-cells. There is an inverse linear relationship between IL-6 levels and nadir Na (p = 0.001). Further studies will be needed to confirm a causative relationship between IL-6 levels and hyponatremia following CD19+ CAR T-cell infusion.

2018-11-01·Cancer Immunology Research1区 · 医学

Selective Targeting of Glioblastoma with EGFRvIII/EGFR Bitargeted Chimeric Antigen Receptor T Cell

1区 · 医学

Article

作者: Wang, Peng ; Gao, Huiping ; Song, Bo ; Shi, Bizhi ; Wang, Huamao ; Jiang, Hua ; Kong, Juan ; Li, Zonghai

AbstractThe heterogeneous expression of EGFRvIII [variant III mutant of epidermal growth factor receptor (EGFR)] in glioblastoma has significant impact on the clinical response to the treatment of EGFRvIII-specific chimeric antigen receptor–engineered T (CAR T) cells. We hypothesized that CAR T cells that could target both EGFRvIII and the form of EGFR expressed on tumor cells, but not EGFR on normal cells, would greatly improve efficacy without inducing on-target, off-tumor toxicity. Therefore, we developed a humanized single-chain antibody, M27, with a single specificity that binds to an epitope found both on wild-type EGFR- and EGFRvIII-overexpressing tumor cells, but not EGFR-expressing normal cells, including primary keratinocytes, on which wild-type EGFR is highly expressed. M27-derived CAR T cells effectively lysed EGFRvIII- or EGFR-overexpressing tumor cells, but showed no observable toxicity on normal cells. Inclusion of the CD137 (4-1BB) costimulatory intracellular domain in the M27-28BBZ CAR provided CAR T cells with higher tumor lysis activity than when not included (as in the M27-28Z CAR). The growth of established EGFR- or EGFRvIII-overexpressing glioma xenografts was suppressed by M27-28BBZ CAR T cells as well. The growth of heterogeneic xenograft tumors, created by mixing EGFR- and EGFR-overexpressing glioblastoma cells, was also effectively inhibited by M27-28BBZ CAR T cells. The survival of mice in the orthotopic models was significantly prolonged after M27-28BBZ CAR T-cell infusion. These results suggested that tumor-selective, bitargeted anti-EGFR/EGFRvIII CAR T cells may be a promising modality for the treatment of patients with EGFR/EGFRvIII-overexpressing glioblastoma. Cancer Immunol Res; 6(11); 1314–26. ©2018 AACR.

100 项与 CD5 CAR T cells(Beijing Boren Hospital) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
T细胞急性淋巴细胞白血病/淋巴瘤	临床1期	中国	Beijing Boren Hospital	2022-07-27
难治性 T 急性淋巴细胞白血病	临床1期	中国	Beijing Boren Hospital	2021-09-14

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05032599 (EHA2024) 人工标引	临床1期	T细胞急性淋巴细胞白血病复发	16	CD5CAR T cells	(壓夢繭遞衊鑰鬱網窪襯) = Adverse events within 30 days included grade 3-4 cytopenias (100%, 92% of which were present prior tolymphodepletion), grade 1-2 cytokine release syndrome (75%), grade 1-2 neurotoxicity (25%) and grade 1 skingraft-versus-host disease (GVHD)(69%) and one grade 3 infection (6%) with no dose-limiting toxicity. 窪鹽積獵窪鑰繭構鏇選 (醖簾蓋齋窪憲鹹衊膚觸 )	积极	2024-05-14
NCT05032599 (EHA2024) 人工标引	临床1期	T细胞急性淋巴细胞白血病复发	16	CD5CAR T cells (received SCT at 35)		积极	2024-05-14
NCT05032599 (ASCO2022) 人工标引	临床1期	难治性 T 急性淋巴细胞白血病	5	CD5 CAR T cells(Beijing Boren Hospital)	(夢選觸廠醖製鬱憲淵餘) = 壓膚觸淵鹹鹹襯積遞構夢蓋鑰襯淵鏇膚構範顧 (製積襯鑰構糧淵憲網網 ) 更多	积极	2022-06-02