Delving into the Latest Updates on CLIC-1901 with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

autologous anti-CD19 Chimeric Antigen Receptor T cells

Target

CD19

Mechanism

CD19 modulators(B-lymphocyte antigen CD19 modulators)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication

Acute Lymphoblastic LeukemiaChronic Lymphocytic LeukemiaNon-Hodgkin Lymphoma

Inactive Indication-

Originator Organization

Ottawa Hospital Research Institute

Active Organization

Ottawa Hospital Research Institute

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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The investigators propose an early phase study defined as a phase I/II trial assessing safety, feasibility and efficacy of CLIC-1901 autologous anti-CD19 Chimeric Antigen Receptor T cells (CAR-T) cells for participants with relapsed/refractory CD19 positive (CD19+) Acute Lymphoblastic Leukemia (ALL) and non-Hodgkin's Lymphoma (NHL). The Initial Stage of the study (n=20 participants) will focus on feasibility and safety while the Extended Stage will include all participants enrolled in the study (n=additional 80 participants for a total of 100) and will focus on efficacy and safety outcomes. In the proposed trial, we will administer our CAR-T cell product to these participants as a single infusion. Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-1901 CAR-T cells. All treatments will be delivered intravenously.

Start Date16 Oct 2019

Sponsor / Collaborator

Ottawa Hospital Research Institute

EUCTR2017-002088-16-IT / Unknown statusPhase 1/2IIT

Phase I/II study of anti-CD19 Chimeric Antigen Receptor-Expressing T cells in pediatric patients affected by relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non Hodgkin Lymphoma - CD19-CAR01

Start Date22 Dec 2017

Sponsor / Collaborator-

100 Clinical Results associated with CLIC-1901

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100 Translational Medicine associated with CLIC-1901

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100 Patents (Medical) associated with CLIC-1901

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30

Literatures (Medical) associated with CLIC-1901

01 Jan 2024·Journal of Pediatric Hematology/Oncology

Cerebral Spinal Fluid Parameters Following CD19-Targeted Therapies in Children and Young Adults

Article

Author: Leib, Shiran ; Vernitsky, Helly ; Toren, Amos ; Aharony-Tevet, Yarden ; Jacoby, Elad ; Bielorai, Bella

The presence of leukocytes in the cerebral spinal fluid (CSF) of patients with acute lymphoblastic leukemia may indicate a relapse in the central nervous system. CD19-directed immunotherapy may increase the blood-brain barrier permeability, leading to neurologic toxicity and infiltrate the CNS. We studied the CSF cell and protein content in 71 consecutive patients who received either CD19 chimeric antigen receptor T cells or blinatumomab. Responding patients had an incidence of 66% and 61% of pleocytosis following blinatumomab or chimeric antigen receptor T cells, respectively. CSF parameters did not correlate with toxicity or prior CNS disease. Routine CSF flow cytometry following immunotherapy to distinguish T-cell infiltration from CNS relapse should be considered.

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.

01 Jun 2022·Pediatric Blood & Cancer

Successful administration of CD19 chimeric antigen receptor T cells in association with severe cyanotic congenital heart disease

Article

Author: Gakenheimer‐Smith, Lindsey ; Harris, Andrew ; Afify, Zeinab ; Staab, Ambur ; Boyer, Michael

100 Deals associated with CLIC-1901

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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 2	CA	Ottawa Hospital Research Institute	16 Oct 2019
Chronic Lymphocytic Leukemia	Phase 2	CA	Ottawa Hospital Research Institute	16 Oct 2019
Non-Hodgkin Lymphoma	Phase 2	CA	Ottawa Hospital Research Institute	16 Oct 2019