A phase I/II single arm study, Safety and Efficacy assessment of the CD19 CAR T cell on pediatric patients with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL)

开始日期2024-06-21

申办/合作机构-

NCT05613348

/ Withdrawn临床1/2期

Humanized CAR19T2 T Cell in Children With Refractory/Relapsed B-cell Leukemia/Lymphoma

This study aims to evaluate the safety and efficacy of humanized Anti-CD19 Chimeric Antigen Receptor-T cell (CAR19T2 T cell) in children with refractory/relapsed B-cell acute lymphoblastic leukemia/lymphoma.

开始日期2022-12-01

申办/合作机构

广州肽康医药科技有限公司

[+1]

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项与 CD19 CAR T-cell(Guangdong Zhaotai Cell Bio-tech Co., LTD) 相关的文献（医药）

2026-02-01·CLINICAL MICROBIOLOGY AND INFECTION

Invasive fungal infections after CD19 chimeric antigen receptor T-cell therapy for B-cell lymphoma: a Lymphoma study association study from the DESCAR-T (Dispositif d’Enregistrement et Suivi des patients traités par CAR-T cells) registry

Article

作者: Lemonnier, François ; Lorente, Cristina Castilla ; Melica, Giovanna ; Eloit, Martin ; Gastinne, Thomas ; Dulery, Rémi ; Durand, Amandine ; Bachy, Emmanuel ; Campidelli, Arnaud ; di Blasi, Roberta ; Latiere, Christelle ; Morschhauser, Franck ; Casasnovas, Olivier ; Le Bras, Fabien ; Joris, Magalie ; Dupont, Vivien ; Denis, Blandine ; Tudesq, Jean-Jacques ; Angebault, Cécile ; Gangneux, Jean-Pierre ; Bouvier, Amélie ; Houot, Roch ; Gabellier, Ludovic ; Gower, Nicolas

OBJECTIVES:

To describe the landscape of invasive fungal infections (IFIs) after chimeric antigen receptor (CAR) T-cell therapy for B-cell malignancies from the French national DESCAR-T registry and evaluate risk factors associated with invasive fungal infections in this population.

METHODS:

We conducted a multicentre cohort study to describe the landscape of IFIs in adults with relapsed or refractory B-cell lymphoma treated with CD19 CAR T-cell therapy. Patients were identified through the French DESCAR-T registry. Clinical and biological data were collected retrospectively. Each IFI was classified according to the European Organization for Research and Treatment of Cancer (EORTC) criteria.

RESULTS:

Among the 1012 patients included in the registry from 2018 to 2022, 32 patients (3.1%) presented with proven (n = 14/32), probable (n = 12/32), or possible (n = 6/32) IFIs. The median time to onset was 29.5 days (IQR 16.5-79.5 days). The most frequent mould infection was invasive aspergillosis, occurring in 11 of 32 patients, whereas the most frequent yeast infection was candidemia occurring in 12 of 32 patients. The IFI-related mortality rate among infected patients was 21.8% (7/32 patients). Multivariate analysis identified several risk factors associated with IFIs: advanced age, number of prior lines of therapy, prior allogeneic haematopoietic cell transplantation, antiinterleukin-1 receptor antagonist treatments, and pre-IFI bacterial infection. The median overall survival of patients with IFIs was 6 months (95% CI, 1.0-20.6) compared with 25.4 months (95% CI, 20.5-32.0) in the noninfected population. The median progression-free survival of patients with IFIs was 3.2 (95% CI, 0.8-18.3) months compared with 5.8 months (95% CI, 4.5-6.7) in the noninfected population.

CONCLUSIONS:

Despite the low incidence of IFI in B-cell lymphoma patients treated with CD19 CAR T-cell therapy, the high infectious mortality underscore the need for individualized prophylaxis and rapid diagnosis for high-risk patients.

2026-01-29·NEW ENGLAND JOURNAL OF MEDICINE

2026-01-16·CLINICAL CANCER RESEARCH

Article

作者: Hernández-Sánchez, María ; Ancos-Pintado, Raquel ; Bastos-Oreiro, Mariana ; Cedena, María-Teresa ; Carbonell, Diego ; Jiménez-Ubieto, Ana ; Tomás-Barberán, Francisco A. ; Linares, María ; Bragado-García, Irene ; Arroyo, Andrés ; Ortiz-Ruiz, Alejandra ; Alonso, Rafael ; Sánchez-Pina, Jose María ; Martín García-Sancho, Alejandro ; Ortega-Hernández, Adriana ; Barba, Pere ; Rodríguez-García, Alba ; Martínez-López, Joaquín ; Castellano, Eva ; García-Vicente, Roberto ; García-Villalba, Rocío ; Leivas, Alejandra ; Gómez-Garre, Dulcenombre ; Valeri, Antonio ; Navarro-Aguadero, Miguel Ángel ; Kwon, Mi ; Carpio, Cecilia ; Modrego, Javier

Abstract:

Purpose::

The microbiota is recognized as an important contributor to the efficacy of immunotherapies. The aim of this study is to analyze the role of gut microbiota and related metabolites in the response of chimeric antigen receptor (CAR) T cells for non-Hodgkin lymphoma.

Experimental Design::

Stool, serum, and clinical data were collected from 84 patients with non-Hodgkin lymphoma from four hospitals before CD19 CAR T-cell treatment. The microbiota was characterized through 16S rRNA gene sequencing, and serum short-chain fatty acids (SCFA) were measured using mass spectrometry. CAR T cells were exposed to butyrate; their in vitro cytotoxicity was determined, and molecular mechanisms were characterized by flow cytometry and RNA sequencing and then assessed in an in vivo model.

Results::

As we confirmed the negative impact of antibiotics on the response, we delved into the mechanisms involved. We showed that they reduce microbiota diversity and that their composition correlates with the response. We identified SCFA-producing bacterial groups, including Prevotella, Ruminococcus, and Butyricicoccus, as having a relatively higher abundance in the microbiota of patients who responded to CAR T cells. Analysis of butyrate levels revealed a positive correlation with survival, potentially representing a novel biomarker of response. Finally, we found that stimulation of CAR T cells with butyrate induced phenotypic and transcriptomic changes associated with enhanced antitumor efficacy.

Conclusions::

Our results support the relationship between microbiota and CAR T-cell therapy major outcomes. Analysis of microbiota led to the identification of SCFAs, especially butyrate, as a prognostic factor, and also provides the basis for considering them as chemical modifiers of CAR T cells to improve their efficacy.

项与 CD19 CAR T-cell(Guangdong Zhaotai Cell Bio-tech Co., LTD) 相关的新闻（医药）

2023-05-08

·GlobeNewswire-Health Care

Enlivex Announces Issuance of European Patent Covering the Use of Allocetra™ to Prevent Cytokine Release Syndrome (CRS) Resulting from CAR T-Cell Therapy

Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced the issuance of a European patent, numbered 3865189, entitled, “Combination Immune Therapy and Cytokine Control Therapy for Cancer Treatment.” The patent provides added intellectual property protection in Europe into at least 2037, with claims covering the use of for Allocetra™ for the prevention or amelioration of cytokine storms in cancer patients receiving CAR T-Cell therapy. ABOUT ALLOCETRA™ Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents. ABOUT ENLIVEX Enlivex is a clinical stage macrophage reprogramming immunotherapy company developing Allocetra™, a universal off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Resetting non-homeostatic macrophages into their homeostatic state is critical for immune system rebalancing and resolution of life-threatening conditions. For more information, visit http://www.enlivex.com. The content above comes from the network. if any infringement, please contact us to modify.

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适应症	最高研发状态	国家/地区	公司	日期
B细胞淋巴瘤	临床2期	中国	广东昭泰细胞生物科技有限公司	2022-12-01
CD19阳性B细胞急性淋巴细胞白血病	临床2期	中国	广东昭泰细胞生物科技有限公司	2022-12-01