Delving into the Latest Updates on Anti-CD19 CAR-T cells(University of Utah) with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

Anti-CD19 Chimeric Antigen Receptor T Cells

Target

CD19

Action

modulators

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication

Acute Lymphoblastic LeukemiaCD19 Expressing MalignanciesDiffuse Large B-Cell Lymphoma

Inactive Indication-

Originator Organization

University of Utah

Active Organization

University of Utah

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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This is an open label, non-randomized, phase 1 study of anti-CD19 CAR-T cells against relapsed CD19 positive NHL, CLL and ALL based in a lymphodepletion regimen (fludarabine and cyclophosphamide) and using a CellReGen-based process for manufacturing CAR-T cells.
This study will utilize a staggered enrollment design with a safety observation period.

Start Date20 Feb 2024

Sponsor / Collaborator

University of Utah

KCT0009199

/ RecruitingPhase 2IIT

Treatment of CD19 Chimeric Antigen Receptor T cells for Pediatric Patients with CD19-positive B-cell Acute Lymphoblastic Leukemia who are Indicated for Hematopoietic Stem Cell Transplantation

Start Date19 Jan 2024

Sponsor / Collaborator

Seoul National University Hospital

NCT04289220

/ Unknown statusPhase 1IIT

A Phase I Clinical Trial of Anti-CD19 Chimeric Antigen Receptor in PiggyBac Transposon-Engineered T Cells for the Treatment of Patients With Relapsed/Refractory/High-risk B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia

Our previous study demonstrated that anti-CD19 chimeric antigen receptor in piggyBac transposon-engineered T cells have strong tumor-killing activity in vitro and therapeutic effects in cell line-derived xenograft models, and no obvious side effects such as neurotoxicity and cytokine storm occurred. Therefore, we want to evaluate the safety and clinical effect of anti-CD19 CAR-T cells in clinical trials.

Start Date15 Mar 2020

Sponsor / Collaborator-

100 Clinical Results associated with Anti-CD19 CAR-T cells(University of Utah)

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100 Translational Medicine associated with Anti-CD19 CAR-T cells(University of Utah)

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100 Patents (Medical) associated with Anti-CD19 CAR-T cells(University of Utah)

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21

Literatures (Medical) associated with Anti-CD19 CAR-T cells(University of Utah)

01 Aug 2023·Current medical science

Donor-derived CD19 CAR-T Cells versus Chemotherapy Plus Donor Lymphocyte Infusion for Treatment of Recurrent CD19-positive B-ALL After Allogeneic Hematopoietic Stem Cell Transplantation.

Article

Author: Wang, Xiao-Qi ; Kong, Pei-Yan ; Zhang, Cheng ; Tan, Xu ; Zhao, Xian-Lan ; Gao, Lei ; Wen, Qin ; Yao, Han ; Gao, Li ; Shen, Yan ; Lou, Shi-Feng ; Zhang, Xi ; Ma, Ying-Ying ; Chen, Guo

OBJECTIVEThis study aimed to compare the efficacy of anti-CD19 chimeric antigen receptor T cells (CAR-T cells) versus chemotherapy plus donor lymphocyte infusion (chemo-DLI) for treating relapsed CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) after allogeneic hematopoietic stem cell transplantation (allo-HSCT).METHODSClinical data of 43 patients with B-ALL who relapsed after allo-HSCT were retrospectively analyzed. Twenty-two patients were treated with CAR-T cells (CAR-T group), and 21 with chemotherapy plus DLI (chemo-DLI group). The complete remission (CR) and minimal residual disease (MRD)-negative CR rates, leukemia-free survival (LFS) rate, overall survival (OS) rate, and incidence of acute graft-versus-host disease (aGVHD), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were compared between the two groups.RESULTSThe CR and MRD-negative CR rates in the CAR-T group (77.3% and 61.5%) were significantly higher than those in the chemo-DLI group (38.1% and 23.8%) (P=0.008 and P=0.003). The 1- and 2-year LFS rates in the CAR-T group were superior to those in the chemo-DLI group: 54.5% and 50.0% vs. 9.5% and 4.8% (P=0.0001 and P=0.00004). The 1- and 2-year OS rates in the CAR-T versus chemo-DLI group were 59.1% and 54.5% vs. 19% and 9.5% (P=0.011 and P=0.003). Six patients (28.6%) with grade 2-4 aGVHD were identified in the chemo-DLI group. Two patients (9.1%) in the CAR-T group developed grade 1-2 aGVHD. Nineteen patients (86.4%) developed CRS in the CAR-T group, comprising grade 1-2 CRS in 13 patients (59.1%) and grade 3 CRS in 6 patients (27.3%). Two patients (9.1%) developed grade 1-2 ICANS.CONCLUSIONDonor-derived anti-CD19 CAR-T-cell therapy may be better, safer, and more effective than chemo-DLI for B-ALL patients who relapse after allo-HSCT.

01 Jul 2023·Blood Reviews

Vaccinations in hematological patients in the era of target therapies: Lesson learnt from SARS-CoV-2

Review

Author: Barcellini, Wilma ; Rampi, Nicolo ; Fattizzo, Bruno

Novel targeting agents for hematologic diseases often exert on- or off-target immunomodulatory effects, possibly impacting on response to anti-SARS-CoV-2 vaccinations and other vaccines. Agents that primarily affect B cells, particularly anti-CD20 monoclonal antibodies (MoAbs), Bruton tyrosine kinase inhibitors, and anti-CD19 chimeric antigen T-cells, have the strongest impact on seroconversion. JAK2, BCL-2 inhibitors and hypomethylating agents may hamper immunity but show a less prominent effect on humoral response to vaccines. Conversely, vaccine efficacy seems not impaired by anti-myeloma agents such as proteasome inhibitors and immunomodulatory agents, although lower seroconversion rates are observed with anti-CD38 and anti-BCMA MoAbs. Complement inhibitors for complement-mediated hematologic diseases and immunosuppressants used in aplastic anemia do not generally affect seroconversion rate, but the extent of the immune response is reduced under steroids or anti-thymocyte globulin. Vaccination is recommended prior to treatment or as far as possible from anti-CD20 MoAb (at least 6 months). No clearcut indications for interrupting continuous treatment emerged, and booster doses significantly improved seroconversion. Cellular immune response appeared preserved in several settings.

01 Apr 2023·Hematological OncologyQ3 · MEDICINE

Efficacy of programmed cell death 1 inhibitor maintenance therapy after combined treatment with programmed cell death 1 inhibitors and anti‐CD19‐chimeric antigen receptor T cells in patients with relapsed/refractory diffuse large B‐cell lymphoma and high tumor burden

Q3 · MEDICINE

Article

Author: Deng, Haobin ; Yuan, Jijun ; Mu, Juan ; Lyu, Cuicui ; Jiang, Yanyu ; Li, Qing ; Deng, Qi ; Wang, Jia ; Shen, Jichun

AbstractWe studied the efficacy and safety of the combined treatment with programmed cell death 1 (PD‐1) inhibitors and anti‐CD19 chimeric antigen receptor (CAR) T‐cell therapy and subsequent PD‐1 inhibitor maintenance treatment in patients with relapsed/refractory (R/R) diffuse large B‐cell lymphoma (DLBCL) and high tumor burden. Forty‐four R/R DLBCL patients with high tumor burden were enrolled in this study. The experimental group of 26 patients received combined therapy with PD‐1 inhibitors and anti‐CD19‐CAR T cells, while the control group of 18 patients received anti‐CD19‐CAR T‐cell therapy alone. The objective response rate (ORR) was 65.39% and 61.11% in the combination and control groups, respectively. The PD‐1 inhibitor maintenance therapy was selected for patients who achieved complete response or partial response in the combination therapy group. Progression‐free survival and overall survival rates in the combination group were higher than those in the control group 3 and 12 months after CAR T‐cell infusion. There was no significant difference in the grade of cytokine release syndrome or immune effector cell associated neurotoxic syndrome between the two groups. In the maintenance therapy group, only eight patients experienced grade 1 Common Terminology Criteria for Adverse Events (CTCAE) and three grade 2 CTCAE. Overall, we found that the ORR was not affected by the combination therapy with PD‐1 inhibitors and anti‐CD19‐CAR T cells. However, patients who had achieved the ORR might benefit from PD‐1 inhibitor maintenance therapy after combination therapy without increased side effects.

100 Deals associated with Anti-CD19 CAR-T cells(University of Utah)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Lymphoblastic Leukemia	Phase 1	United States	University of Utah	20 Feb 2024
CD19 Expressing Malignancies	Phase 1	United States	University of Utah	20 Feb 2024
Diffuse Large B-Cell Lymphoma	Phase 1	United States	University of Utah	20 Feb 2024