A Trial to Evaluate the Safety and Preliminary Efficacy of iNK in the Treatment of Subjects With Solid Tumor

Solid tumor is a disease with high mortality rates. The aim of this trial is to investigate the safety, efficacy of iNK in subjects with solid tumor. It is a dose escalation and extension trial.

Inclusion criteria

• ≥18 years old.
• Subjects with recurrent or metastatic solid tumors that cannot accept radical locoregional therapy;
• Systemic standard treatment failed or cannot tolerate serious toxicity or lack of standard treatment.
• Have 1 or more focus can be accessed according to RECIST 1.1
• Eastern Cooperative Oncology Group(ECOG):0-1
• Expected survival period over 3 months
• Have acceptable organ function and the results of laboratory examination meet the request below:

Hepatic Insufficiency (ALT) and Aspartate aminotransferase（AST）≤3xULN(upper limit of normal);Total Bilirubin≤3xULN；Creatinine≤3xULN；White blood cell count ≥3.0x10^9/L; Absolute Neutrophil Count≥1.0x10^9/L

• Agree to contraception
• Subjects who understand and voluntarily sign the Informed Consent Form（ICF)

Exclusion criteria

• Central nervous system metastasis or meningeal metastasis with clinical symptoms；
• With active infection during screening
• Have serious or uncontrolled basic diseases;
• Have continuous adverse event caused by previous anti-tumor therapy that might affect the evaluation of drug safety；
• Accept anti-tumor therapy within 28 days before first injection;
• Accept general anesthesia surgery or radiation therapy within 28 days before first injection;
• Accept live vaccine or attenuated live vaccine within 28 days before first injection;
• Allergy to known drug components;
• Serous cavity effusion requiring clinical intervention；
• Pregnancy or prepare to pregnant during the treatment;
• Other situations that not suitable to participate into this trial.