A Phase 1, Open Label, Multicenter Trial to Assess the Safety, Tolerability and Efficacy of MB-106 in Patients with Relapsed or Refractory CD20+ B-Cell NHL or CLL

摘要 在这一应用中，我们建议优化野马生物合适的MB-106的可行性及其对B- 细胞性非霍奇金淋巴瘤(NHL)和慢性淋巴细胞性淋巴瘤(CLL) 复发性或难治性CD20 B细胞NHL或CLL患者的最佳剂量。 虽然目前的分子靶向治疗已经导致了长时间的缓解，但到目前为止 对NHL和CLL癌症没有根治性的治疗方法。因此，需要一种创新的方法来 个体化和特效性的治疗，可以持续到缓解期。CAR T细胞疗法等建议 在这里，是一种细胞免疫疗法，使用过继T细胞表达嵌合抗原受体特异性 靶向肿瘤相关的B细胞抗原。建议的方法是高度个性化的，因为每一种产品 为每个患者单独制造。 在这项直接到第二阶段的临床试验中，将测试MB-106的有效性、安全性，并确定最佳剂量 对病人来说。建议进行一项开放标记的干预性、非随机过继T细胞免疫治疗研究 扩大对MB-106在血液、骨髓和其他测量的疾病部位的影响的了解 按输液后细胞因子水平计算。在本项目结束时，MB-106的建议剂量为 患者将被确定，并将作为未来临床试验和最终临床治疗的基础 使用。

ABSTRACT In this application, we propose to optimize the feasibility of Mustang Bio's propriety MB-106 and its impact on B- cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphatic Lymphoma (CLL) patients and determine an optimal dosage for patients with relapsed or refractory CD20+ B-cell NHL or CLL. While the current courses of molecular targeted therapies have resulted in prolonged remissions, to date there is no curative therapeutic for NHL and CLL cancers. Therefore, an innovative approach is needed for an individualized and specific therapy that can persist past remission dates. CAR T cell therapy such as proposed here, is a cellular immunotherapy that uses adoptive T-cells expressing a chimeric antigen receptor specific to targeting tumor-associated B- cell antigens. The methodology proposed is highly individualized, as each product is manufactured individually for each patient. In this Direct to Phase 2 clinical trial, MB-106 will be tested for efficacy, safety, and determine the optimal dosage for patients. Proposed is an open-label interventional, non-randomized adoptive T-cell immunotherapy study to broaden the understanding the impact of MB-106 in blood, bone marrow, and other sites of disease measured by cytokine levels post infusion. At the conclusion of this project, the recommended dosage of MB-106 for patients will be determined and will be used as the basis for treatment in future clinical trials and ultimate clinical use.