UH Seidman癌症中心开展针对复发和难治性多发性骨髓瘤患者的BAFF CAR - T一期临床试验

2022年1月，来自UH Seidman癌症中心和凯斯西储大学的一个研究小组发表了一份开创性的报告，详细介绍了一种嵌合抗原受体(CAR) T细胞治疗B细胞白血病的新方法。

In January 2022, a research team from UH Seidman Cancer Center and Case Western Reserve University published a groundbreaking report , detailing a novel approach to chimeric antigen receptor (CAR) T-cell therapy for B-cell cancers.

新的B细胞活化因子(BAFF) CAR - T产品，由UH Seidman癌症中心和凯斯西储大学的科学家Reshmi Parameswaran博士及其同事开发，特异性结合三种受体中的每一种，而不是一种- BAFF- r, BCMA和TACI，提供更多的治疗选择，并防止目前在仅针对CD19的CAR - T疗法中发现的抗原逃逸问题。

The new B-cell activating factor (BAFF) CAR T product, developed by UH Seidman Cancer Center and Case Western Reserve University scientist Reshmi Parameswaran, MS, PhD, and colleagues, binds specifically to each of three receptors instead of one – BAFF-R, BCMA and TACI, providing more therapeutic options and guarding against the problem of antigen escape currently found in CAR T therapies that solely target CD19.

实验结果表明，BAFF CAR - T能有效杀伤多种B细胞白血病，BAFF CAR - T细胞对套细胞淋巴瘤、多发性骨髓瘤和急性淋巴细胞白血病异种移植小鼠模型具有强大的体外和体内细胞毒性。

Experimental results showed that the BAFF CAR T is effective at killing multiple B-cell cancers, with robust in vitro and in vivo cytotoxicity exerted by BAFF CAR T-cells against mantle cell lymphoma, multiple myeloma and acute lymphoblastic leukemia xenograft mouse models.

现在，仅仅两年之后，这些重要的发现为复发和难治性多发性骨髓瘤患者的一期BAFF CAR - T临床试验奠定了基础。

Now just two short years later, these crucial findings are the basis for the Phase I BAFF CAR T clinical trial for patients with relapsed and refractory multiple myeloma.

新的多发性骨髓瘤试验将在UH Seidman进行，将有多达20名复发或难治性骨髓瘤患者和三线治疗失败的患者，三线治疗包括免疫调节剂，蛋白酶体抑制剂和抗CD38单克隆抗体。

The new multiple myeloma trial at UH Seidman will proceed with up to 20 patients with relapsed or refractory myeloma and three or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody.

其主要目标是确定BAFF CAR - T细胞的最大耐受剂量和推荐剂量，用于II期试验。

Its primary goal is to determine the maximum tolerated dose and recommended dose of BAFF CAR T-cells for a Phase II trial.

次要目标包括建立毒性谱、客观反应率、完全反应率、反应持续时间、无进展生存期、总生存期、不良事件发生率和针对BAFF CAR - T细胞的抗体发生率。

Secondary objectives include establishing the toxicity profile, objective response rate, complete response rate, duration of response, progression-free survival, overall survival, the incidence of adverse events and the incidence of antibodies against the BAFF CAR T-cells.

这项研究是通过大学医院和Luminary Therapeutics(一家总部位于明尼阿波利斯的生物技术初创公司)之间的协议进行的。

The study is being done through an agreement between University Hospitals and Luminary Therapeutics, a biotech start-up based in Minneapolis.

Luminary是一家同种异体CAR - T药物开发公司，其项目针对B细胞恶性肿瘤、自身免疫性疾病和实体瘤。

Luminary is an allogeneic CAR T drug development company with programs addressing B-cell malignancies, autoimmune disease and solid tumors.