[Translation] A multicenter, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor efficacy of YKST02 in the treatment of relapsed/refractory multiple myeloma
剂量递增阶段
(1)主要目的:
评价YKST02在复发/难治性多发性骨髓瘤患者中的安全性和耐受性。
(2)次要目的:
1)评价YKST02在复发/难治性多发性骨髓瘤患者中的药代动力学特征;
2)评价YKST02在复发/难治性多发性骨髓瘤患者中的免疫原性;
3)初步探索YKST02在复发/难治性多发性骨髓瘤患者中的抗肿瘤活性。
(3)探索性目的:
探索YKST02的药效动力学特征及生物标志物。
剂量扩展阶段
(1)主要目的:
评价YKST02选定剂量下在复发/难治性多发性骨髓瘤患者中的安全性、耐受性和初步抗肿瘤疗效[ORR(sCR+CR+VGPR+PR)]。
(2)次要目的:
1)评价YKST02选定剂量下在复发/难治性多发性骨髓瘤患者中的PK特征;
2)进一步评价YKST02在复发/难治性多发性骨髓瘤患者中的免疫原性。
(3)探索性目的:
探索YKST02的药效学特征及生物标志物。
[Translation] Dose escalation phase
(1) Primary objective:
To evaluate the safety and tolerability of YKST02 in patients with relapsed/refractory multiple myeloma.
(2) Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of YKST02 in patients with relapsed/refractory multiple myeloma;
2) To evaluate the immunogenicity of YKST02 in patients with relapsed/refractory multiple myeloma;
3) To preliminarily explore the anti-tumor activity of YKST02 in patients with relapsed/refractory multiple myeloma.
(3) Exploratory objective:
To explore the pharmacodynamic characteristics and biomarkers of YKST02.
Dose expansion phase
(1) Primary objective:
To evaluate the safety, tolerability and preliminary anti-tumor efficacy [ORR (sCR+CR+VGPR+PR)] of YKST02 at selected doses in patients with relapsed/refractory multiple myeloma.
(2) Secondary objectives:
1) To evaluate the PK characteristics of YKST02 at selected doses in patients with relapsed/refractory multiple myeloma;
2) To further evaluate the immunogenicity of YKST02 in patients with relapsed/refractory multiple myeloma.
(3) Exploratory objectives:
To explore the pharmacodynamic characteristics and biomarkers of YKST02.