Delving into the Latest Updates on MB-CART20.1(Miltenyi) with Synapse

Overview

Basic Info

Drug Type

Autologous CAR-T

Synonyms

Anti-CD20 CAR T cells (Miltenyi), CD20-targeting CAR T Cells (Miltenyi)

+ [1]

Target

CD20

Mechanism

CD20 inhibitors(B-lymphocyte antigen CD20 inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [1]

Active Indication

B-cell lymphoma recurrentB-cell lymphoma refractoryMelanoma+ [2]

Inactive Indication

Melanoma, Cutaneous MalignantMetastatic melanoma

Originator Organization

Miltenyi Biotec, Inc.

Active Organization

Miltenyi Biomedicine GmbHStartup

Inactive Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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This is a phase l multi-centric, single arm, prospective, open, dose-escalation study in patients with unresectable stage III oder IV melanoma. The trial will include 15 adult patients. The trial is a classic 3+3 design with 1 Log dose increments and maximum 3 dose levels of the intravenously administered MB-CART20.1.

Start Date08 Mar 2019

Sponsor / Collaborator

Miltenyi Biomedicine GmbHStartup

[+1]

DRKS00016573Phase 1

Multicenter phase I trial of MB-CART20.1 for the treatment of patients with metastatic melanoma - MB-CART20.1 Melanoma

Start Date05 Mar 2019

Sponsor / Collaborator

Miltenyi Biomedicine GmbHStartup

100 Clinical Results associated with MB-CART20.1(Miltenyi)

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100 Translational Medicine associated with MB-CART20.1(Miltenyi)

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100 Patents (Medical) associated with MB-CART20.1(Miltenyi)

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15

Literatures (Medical) associated with MB-CART20.1(Miltenyi)

01 Dec 2024·American Journal of Hematology

C‐CAR066, a novel fully human anti‐CD20 CAR‐T therapy for relapsed or refractory large B‐cell lymphoma after failure of anti‐CD19 CAR‐T therapy: A phase I clinical study

Article

Author: Liang, Aibin ; Liu, Wei ; Li, Jing ; Zou, Dehui ; Yao, Xin ; Zhu, Shigui ; Li, Ping ; Qiu, Lugui ; Zheng, Chengxiao ; Huang, Jiaqi ; Yao, Yihong ; Zhu, Dan ; Zhou, Lili ; Ye, Shiguang ; Zhu, Kevin

AbstractManaging large B‐cell lymphoma (LBCL) that is refractory to or relapsed after chimeric antigen receptor (CAR)‐T therapy remains a significant challenge. Here we aimed to investigate the safety and efficacy of C‐CAR066, an autologous fully human anti‐CD20 specific CAR‐T, for relapsed/refractory LBCL after failure of anti‐CD19 CAR‐T therapy. This first‐in‐human, single‐arm, phase 1 study was conducted at two sites in China. Eligible patients had to be histologically confirmed with CD20‐positive LBCL and must have received prior anti‐CD19 CAR‐T therapy. Patients received a single intravenous infusion of C‐CAR066 at a target dose of 2.0 × 106 or 3.0 × 106 CAR‐T cells/kg. The primary endpoint was the incidence of adverse events (AEs). As of October 10, 2023, 14 patients had received C‐CAR066. The most common AEs of Grade 3 or higher were hematological toxicities. Cytokine release syndrome occurred in 12 (85.7%) patients, with only one was Grade 4 event. No patient experienced immune effector cell‐associated neurotoxicity syndrome events. The overall response rate was 92.9% with a complete response rate of 57.1%. With a median follow‐up of 27.7 months (range, 3.3–40.9), the median progression‐free survival and overall survival were 9.4 months (95% CI, 2.0 to NA) and 34.8 months (95% CI, 7.5 to NA), respectively. C‐CAR066 demonstrated a manageable safety profile and promising efficacy in patients in whom prior anti‐CD19 CAR‐T therapies had failed, providing a promising treatment option for those patients. This trial was registered with ClinicalTrials.gov, NCT04316624 and NCT04036019.

01 Apr 2024·Journal for ImmunoTherapy of Cancer

Development of a compact bidirectional promoter-driven dual chimeric antigen receptor (CAR) construct targeting CD19 and CD20 in the Sleeping Beauty (SB) transposon system

Article

Author: Halpin, Josh ; Khaniya, Asmita ; Rad, S M Ali Hossieni ; Tawinwung, Supannikar ; McLellan, Alexander ; Hirankarn, Nattiya ; Suppipat, Koramit

BackgroundA bidirectional promoter-driven chimeric antigen receptor (CAR) cassette provides the simultaneous expression of two CARs, which significantly enhances dual antigen-targeted CAR T-cell therapy.MethodsWe developed a second-generation CAR directing CD19 and CD20 antigens, incorporating them in a head-to-head orientation from a bidirectional promoter using a single Sleeping Beauty transposon system. The efficacy of bidirectional promoter-driven dual CD19 and CD20 CAR T cells was determined in vitro against cell lines expressing either, or both, CD19 and CD20 antigens. In vivo antitumor activity was tested in Raji lymphoma-bearing immunodeficient NOD-scid IL2Rgammanull(NSG) mice.ResultsOf all tested promoters, the bidirectional EF-1αpromoter optimally expressed transcripts from both sense (CD19-CAR) and antisense (GFP.CD20-CAR) directions. Superior cytotoxicity, cytokine production and antigen-specific activation were observed in vitro in the bidirectional EF-1αpromoter-driven CD19/CD20 CAR T cells. In contrast, a unidirectional construct driven by the EF-1αpromoter, but using self-cleaving peptide-linked CD19 and CD20 CARs, showed inferior expression and in vitro function. Treatment of mice bearing advanced Raji lymphomas with bidirectional EF-1αpromoter-driven CD19/CD20 CAR T cells effectively controlled tumor growth and extended the survival of mice compared with group treated with single antigen targeted CAR T cells.ConclusionThe use of bidirectional promoters in a single vector offers advantages of size and robust CAR expression with the potential to expand use in other forms of gene therapies like CAR T cells.

01 Dec 2023·Transfusion and Apheresis Science

Leukapheresis for CAR-T cell production and therapy

Review

Author: Nagler, Arnon ; Pessach, Ilias

Chimeric antigen receptor (CAR) T-cell therapy is an effective, individualized immunotherapy, and novel treatment for hematologic malignancies. Six commercial CAR-T cell products are currently approved for lymphatic malignancies and multiple myeloma. In addition, an increasing number of clinical centres produce CAR-T cells on-site, which enable the administration of CAR-T cells on site. The CAR-T cell products are either fresh or cryopreserved. Manufacturing CAR-T cells is a complicated process that begins with leukapheresis to obtain T cells from the patient's peripheral blood. An optimal leukapheresis product is crucial step for a successful CAR-T cell therapy; therefore, it is imperative to understand the factors that may affect the quality or T cells. The leukapheresis for CAR-T cell production is well tolerated and safe for both paediatric and adult patients and CAR-Τ cell therapy presents high clinical response rate in many studies. CAR-T cell therapy is under continuous improvement, and it has transformed into an almost standard procedure in clinical haematology and stem cell transplantation facilities that provide both autologous and allogeneic stem cell transplantations. In patients suffering from advanced haematological malignancies, CAR-T cell therapy shows incredible antitumor efficacy. Even after a single infusion of autologous CD19-targeting CAR-T cells in patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) and acute lymphoblastic leukaemia (ALL), long lasting remission is observed, and a fraction of the patients are being cured. Future novel constructs are being developed with better T cell persistence and better expansion. New next-generation CAR-T cells are currently designed to avoid toxicities such as cytokine release syndrome and neurotoxicity.

100 Deals associated with MB-CART20.1(Miltenyi)

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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 recurrent	Phase 2	DE	Miltenyi Biomedicine GmbHStartup	25 Sep 2018
B-cell lymphoma refractory	Phase 2	DE	Miltenyi Biomedicine GmbHStartup	25 Sep 2018
Melanoma	Phase 1	DE	Miltenyi Biomedicine GmbHStartup	12 Aug 2022
Melanoma, Cutaneous Malignant	Phase 1	DE	Miltenyi Biomedicine GmbHStartup	08 Mar 2019
Metastatic melanoma	Phase 1	DE	Miltenyi Biomedicine GmbHStartup	08 Mar 2019