NCT06897228

PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors

A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial on the Safety and Efficacy of PANK-003 Cell Injection Combined with Standard Adjuvant Chemotherapy After Surgery in Patients with Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shenzhen Celconta Life Science Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Solid Tumors, Adult

Interventions

Type	Name	Description
DRUG	PANK-003 cell injection	PANK-003 cell injection

Timeline

• Start date: 2024-02-18
• Primary completion: 2027-01-01
• Completion: 2027-03-01
• First posted: 2025-03-26
• Last updated: 2025-03-26

Locations

1 site across 1 country: China