CAR.BiTE-γδ T (CAR001)

◎產品編號：CAR001
◎產品名稱：抗原嵌合受體T細胞CAR.BiTE-γδ T細胞 (Nb-CAR.BiTE-γδT)
◎特色：
1.全世界第1例可異體並以HLA-G CAR.BiTE治療實體癌為靶點的療法!
2.適應症：惡性腦癌、非小細胞肺癌、三陰性乳癌、大腸直腸癌
3.無需白血球分離、淋巴球清除或HLA配對

Product: CAR001
Product Name: CAR.BiTE–γδ T Cells (Nb-CAR.BiTE-γδT)
Key Features:
1. The world’s first allogeneic CAR.BiTE therapy targeting solid tumors via HLA-G.
2. Indications: Glioblastoma, Non Small Cell Lung Cancer, Tripple Negative Breast Cancer, Colorectal cancer.
3.No leukocyte separation, lymphocyte clearance, or HLA matching required.

CAR001 新一代的免疫治療製劑

CAR001 是一種 mRNA 工程的 γδ T 細胞載體，融合了嵌合抗原受體（CAR）與 γδ T 細胞本身的先天免疫特性，可透過靜脈注射給藥，賦予患者強大的抗腫瘤活性與組織浸潤能力。
CAR001 is an allogeneic, off-the-shelf γδ T cell therapy engineered via mRNA technology to transiently express a chimeric antigen receptor (CAR). Administered intravenously, CAR001 is intended to deliver potent anti-tumor activity with improved safety and manufacturability, particularly for patients with relapsed or refractory solid tumors.

Anti-HLA-G CAR-Receptor

人類白血球抗原 G（Human Leukocyte Antigen G，HLA-G）為一種在多種實體腫瘤中新生表現的腫瘤相關抗原。
Human leukocyte antigen G (HLA-G) is a neo-expressed tumor-associated antigen (TAA) in a large proportion of solid tumors.

Gamma-Delta T cell (γδT)

γδ T 細胞可直接誘導腫瘤細胞毒殺作用，並具備非主要組織相容性複合體的抗腫瘤活性，因而可降低移植物對宿主疾病（GvHD）的發生風險。
γδ T cells can induce cytotoxicity directly and also exhibit major histocompatibility complex (MHC)-independent anti-tumor activities, which reduces graft-versus-host disease (GvHD).

Bispecific T-cell Engager (BiTE)

BiTE 為一種人工設計的雙特異性抗體結構，可同時結合腫瘤細胞表面的 PD-L1 與 T 細胞上的 CD3ε，藉此引導 T 細胞精準攻擊腫瘤細胞
BiTE is an artificial bispecific antibody construct that simultaneously binds PD-L1 on tumor cells and CD3ε on T cells.

為何選擇 γδT 細胞 ?

γδ T 細胞不同於傳統 αβ T 細胞，其 T 細胞受體由 γ 與 δ 鏈所組成，使其能在 MHC 非限制性的情況下辨識與攻擊腫瘤細胞，不易引發移植物對宿主疾病（GvHD），因此非常適合用於異體（Allogeneic）細胞療法平台。
此外，γδ T 細胞具有先天與適應性雙重免疫能力，能同時利用天然細胞毒性與 CAR 介導的抗腫瘤機制，提高療效可能性。

CAR001 的設計與機制

【CAR 與 mRNA 設計】
經CLIA實驗室認證的健康捐贈者的血液中採集γδ T細胞，然後進行mRNA轉染以引導CAR的表現。

這種基於mRNA的工程化過程能夠精確調控CAR的表達量和持續時間，從而在抗腫瘤效力和安全性之間取得良好的平衡。

轉染後，我們的mRNA-γδ T細胞（CAR001）將進行冷凍保存，可作為隨去隨用的免疫細胞療法。

【mRNA-Based CAR Engineering】

Donor-derived γδ T cells are first collected from a healthy donor that are certified by CLIA lab, followed by mRNA transduction to introduce transient CAR expression.

This mRNA-based engineering process allows CAR expression to be precisely regulated in both level and duration, supporting a favorable balance between anti-tumor potency and safety.

After transduction, the engineered mRNA- γδ T cells (CAR001) are cryopreserved and available as an off-the-shelf cell therapy.

醫藥事業：免疫細胞技術平台

CAR.BiTE-γδ T (CAR001)

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抗原嵌合受體T 細胞 ( CAR.BiTE-γδ T )