A single-center, single-arm, dose-escalation exploratory clinical trial on the safety and efficacy of PANK-003 cell injection(Peripheral blood-derived allogeneic natural killer cells )combined with standard adjuvant chemotherapy after surgery in patients with solid tumors
Understand and voluntarily sign the informed consent form;
At the time of screening, the age should be between 18 and 75 years old (inclusive), regardless of gender;
Patients who have been histologically confirmed or diagnosed by imaging (computed tomography (CT) examination, magnetic resonance imaging (MRI) examination or positron emission tomography (PET) scan CT (PET/CT)) as postoperative patients with malignant solid tumors;
Patients who have undergone surgical treatment and are going to receive or are currently undergoing postoperative adjuvant chemotherapy;
Pregnant or lactating women;
Individuals with a history of allergy to any component of the cell product;
Patients with other malignant tumors, except for the following situations: cured non-melanoma skin cancer, in-situ cervical cancer, localized prostate cancer, superficial bladder cancer, and other malignant tumors with a disease-free survival period of more than 5 years;
Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg), positive for hepatitis B e antibody (HBe-Ab) and/or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is greater than the lower limit of measurability; positive for hepatitis C antibody (HCV-Ab); positive for Treponema pallidum antibody (TP-Ab); positive for human immunodeficiency virus (HIV) antibody test; anyone meeting any one of these items;
Single group
PANK-003 cell injection
DrugPANK-003 cell injection
Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT) in the dose escalation phase
Incidence of Treatment Related adverse events (AEs)
Incidence of Treatment Related AEs, AEs of special interest
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) in the dose escalation phase
Evaluate the disease - free survival (DFS)
The time from the date of first administration of PANK-003 cell injection to tumor recurrence or death from any cause
Evaluate the overall survival (OS)
The time from the date of first administration of PANK-003 cell injection to death from any cause
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