[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of RJK-RT2831 injection in patients with hematological malignancies
1.主要目的:评估 RJK-RT2831 在恶性血液肿瘤受试者中的安全性、耐受性和最大耐受剂量。确定 RJK-RT2831 治疗恶性血液肿瘤受试者的扩展期推荐剂量。
2.次要目的:评估 RJK-RT2831 在恶性血液肿瘤受试者中单、多次给药的药代动力学特征。评估 RJK-RT2831 在恶性血液肿瘤受试者中的初步抗肿瘤活性。评估 RJK-RT2831 在恶性血液肿瘤受试者中的免疫原性。
[Translation] 1. Primary objectives: To evaluate the safety, tolerability and maximum tolerated dose of RJK-RT2831 in subjects with hematological malignancies. To determine the recommended dose of RJK-RT2831 for the extension phase of the treatment of subjects with hematological malignancies.
2. Secondary objectives: To evaluate the pharmacokinetic characteristics of single and multiple administrations of RJK-RT2831 in subjects with hematological malignancies. To evaluate the preliminary anti-tumor activity of RJK-RT2831 in subjects with hematological malignancies. To evaluate the immunogenicity of RJK-RT2831 in subjects with hematological malignancies.