Delving into the Latest Updates on Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

AntiCD19/CD22 CART cell therapy Shanghai UnicarTherapy Biomedicine Technology

Target

CD19 x CD22

Mechanism

CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), CD22 inhibitors(CD22 inhibitors), Gene transference

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Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases

Active Indication

CD19-positive B-cell acute lymphoblastic leukemiaRefractory B Acute Lymphoblastic Leukemia

Inactive Indication

B-cell lymphoma refractoryNon-Hodgkin's lymphoma refractoryRecurrent Non-Hodgkin Lymphoma

Originator Organization

Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.

Active Organization

Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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Patients with relapsed or refractory lymphoma often develop resistance to chemotherapy. Chimeric antigen receptor-modified T cell (CART) therapy showed promising effect in B-cell malignancies these years. CD19 and CD22 are proteins expressed on the surface of the lymphoma cells in patients with CD19+CD22+ lymphoma. The CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22. This is a phase 2 trial to study the safety and efficacy of dual specificity CD19 and CD22 CAR-T cell immunotherapy for CD19+CD22+ relapsed and refractory lymphoma.

Start Date01 Jan 2018

Sponsor / Collaborator

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

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NCT03614858 / RecruitingPhase 1/2

Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

This is a single center, open-label ,phase 1/2 study to evaluate the safety and efficacy of targeted CD19/CD22 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19/CD22 positive Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.

Start Date01 Sep 2017

Sponsor / Collaborator

Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.

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100 Clinical Results associated with Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology)

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100 Translational Medicine associated with Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology)

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100 Patents (Medical) associated with Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology)

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1

Literatures (Medical) associated with Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology)

Frontiers in Immunology

Case Report: Post-CAR-T Infusion HBV Reactivation in Two Lymphoma Patients Despite Entecavir Preventive Therapy

Author: Zheng, Miao ; Yang, Li ; Bao, Yuhan ; Yang, Yang ; Ma, Yaxian ; Chen, Liting

Hepatitis B virus (HBV) reactivation is a common complication in chronic or resolved HBV infection patients undergoing immunosuppressive chemotherapy. Furthermore, few articles have been published regarding the risk of HBV reactivation in lymphoma patients receiving chimeric antigen receptor (CAR) T-cell therapy and anti-HBV prophylaxis. Few guidelines or clear optimal strategies are available for managing these patients. Here, we present two cases of patients who underwent CAR-T-cell cocktail therapy with anti-CD19 and anti-CD22 CAR (CAR19/22) T cell for lymphoma. Patients had previous history of HBV infection, and blood tests on initial admission indicated positive results for hepatitis B surface antigen (HBsAg), antibody to hepatitis B core antigen (anti-HBc), and antibody to hepatitis B e antigen (anti-HBe), while serum HBV DNA level was undetectable. Therefore, two patients received entecavir as antiviral prophylactic therapy during their entire treatment. They were diagnosed with HBV reactivation based on positive serum HBV DNA test results, 2 weeks after CAR-T-cell infusion. Liver function assay indicated elevated levels of alanine transaminase (ALT) and aspartate transaminase (AST), combined with increased levels of total bilirubin (TBIL) and direct bilirubin (DBIL). Subsequently, they received anti-HBV treatment with entecavir and tenofovir. As a result, their serum HBV DNA copies and AST/ALT levels returned to normal after 1 week. These cases show that there is a risk of HBV reactivation in lymphoma patients with CAR-T-cell therapy despite entecavir preventive therapy, and combination treatment of entecavir and tenofovir may be an effective treatment option for such patients with HBV reactivation.

100 Deals associated with Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
B-cell lymphoma refractory	Phase 2	CN	Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.	01 Aug 2020
Non-Hodgkin's lymphoma refractory	Phase 2	CN	Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.	01 Aug 2020
Recurrent Non-Hodgkin Lymphoma	Phase 2	CN	Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.	01 Aug 2020
CD19-positive B-cell acute lymphoblastic leukemia	Phase 2	CN	Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.	01 Sep 2017
Refractory B Acute Lymphoblastic Leukemia	Phase 2	CN	Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd.	01 Sep 2017

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03614858 \| NCT03919240 (ASH2021) Manual	Phase 1/2	CD19-positive B-cell acute lymphoblastic leukemia	-	Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) (tandem)	(lshmsyakfc) = Severe cytokine release syndrome (CRS, Grade ≥ 3) occurred in 25.0% of patients in CD19 group, 18.4% of patients in tandem CD19/CD22 group, and 23.1% in sequential CD19/CD22 group (P=0.641). ycvtsitdhn (sosiwvnltr )	Positive	05 Nov 2021
				Anti-CD19/CD22 CAR-T cell therapeutics (Shanghai Unicar-Therapy Bio-medicine Technology) (sequential)