[Translation] To evaluate the multi-center, open-label, single-arm phase I/II clinical study of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in Chinese patients with relapsed/refractory lymphoma
I 期剂量递增阶段:
主要目的:
1. 观察重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤患者的安全性和耐受性;
2. 确定Ⅱ期临床推荐剂量(RP2D)和最大耐受剂量(MTD)。
Ⅱ期疗效探索及确证阶段:
主要目的:
1. 评估重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤患者的疗效。
次要目的:
1. 评估重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤的安全性;
2. 评估重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤的药代动力学特征;
3. 评估重组人源化抗CD47/PD-1 双功能抗体HX009 注射液治疗复发/难治性淋巴瘤的免疫原性。
[Translation] Phase I dose escalation phase:
main purpose:
1. To observe the safety and tolerability of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of patients with relapsed/refractory lymphoma;
2. Determine the recommended dose (RP2D) and maximum tolerated dose (MTD) for phase II clinical trials.
Phase II efficacy exploration and confirmation stage:
main purpose:
1. To evaluate the efficacy of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of patients with relapsed/refractory lymphoma.
Secondary purpose:
1. To evaluate the safety of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of relapsed/refractory lymphoma;
2. To evaluate the pharmacokinetics of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of relapsed/refractory lymphoma;
3. To evaluate the immunogenicity of recombinant humanized anti-CD47/PD-1 bifunctional antibody HX009 injection in the treatment of relapsed/refractory lymphoma.