Hangzhou Hansi Biological Pharmaceutical Co., Ltd.

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. To determine the recommended dose (RP2D) and maximum tolerated dose (MTD) for Phase II clinical trials. Phase II efficacy exploration and confirmation phase: 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 objectives: 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 pharmacokinetic characteristics 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.

Primary objective: To evaluate the efficacy of HX009 injection according to the objective response rate (ORR) assessed by an independent review committee (IRC). Secondary objectives: To evaluate the efficacy of HX009 injection in patients with advanced solid tumors according to the ORR assessed by the investigator; To evaluate the duration of response (DOR) of HX009 injection in patients with advanced solid tumors; To evaluate the disease control rate (DCR) of HX009 injection in patients with advanced solid tumors; To evaluate the progression-free survival (PFS) of HX009 injection in patients with advanced solid tumors; To evaluate the overall survival (OS) of HX009 injection in patients with advanced solid tumors; To evaluate the safety and tolerability of HX009 injection in patients with advanced solid tumors; To evaluate the pharmacokinetics (PK) of HX009 injection; To evaluate the anti-drug antibodies (ADA) and neutralizing antibodies (Nab) after infusion of HX009 injection; To evaluate the peripheral blood T cell surface receptor occupancy (RO) after infusion of HX009 injection. Exploratory purpose: To explore the biomarkers related to the efficacy of HX009 injection (including PD-L1 expression, CD47 expression and peripheral blood ct DNA), and their relationship with adverse events.