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
This project is a prospective, single-arm, open-label, single-dose, multiple-administration dose-finding study, which aims to evaluate the safety, tolerability, and efficacy characteristics of the PANK-003 cell preparation in subjects after adjuvant chemotherapy following surgery for solid tumors. The study will enroll subjects with pathologically diagnosed solid tumors (lung cancer, esophageal cancer, gastric cancer, breast cancer) who have received adjuvant chemotherapy after surgical treatment or after neoadjuvant therapy plus surgical treatment. The study includes a screening period, a treatment period, and an observation and follow-up period. The main objectives : To evaluate the safety and tolerability of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with solid tumors. The secondary objectives : To preliminarily evaluate the efficacy of multiple injections of PANK-003 cell injection combined with standard postoperative adjuvant chemotherapy in the treatment of patients with solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
PANK-003 cell injection
AnYang Tumor Hospital
Anyang, Henan, China
RECRUITINGDose limiting toxicity (DLT)
Dose limiting toxicity (DLT) in the dose escalation phase
Time frame: 21 days after the completion of a single administration
Incidence of Treatment Related adverse events (AEs)
Incidence of Treatment Related AEs, AEs of special interest
Time frame: 1 year
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) in the dose escalation phase
Time frame: 21 days after the completion of a single administration
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
Time frame: 1 year
Evaluate the overall survival (OS)
The time from the date of first administration of PANK-003 cell injection to death from any cause
Time frame: 1 year
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