NCT07096882

SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical Resection

Phase I Clinical Trial of SDTM001 Injection as Adjuvant Treatment for NSCLC Patients With Driver-gene-negative and Negative PD-L1 Expression After Radical Surgical Resection

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Cytocraft Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety profile and tolerability of SDT-M001 injection in NSCLC patients with driver-gene-negative and negative PD-L1 expression after radical surgical resection; to determine the recommended Phase II dose (RP2D).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	SDT-M001 injection	Cascade primed immune cells(CAPRI); SDT-M001 injection is administered at three dose levels:1.5e9 cells, 3e9 cells,6e9 cells. The cells will be reinfused in 3 divided doses, administered every other day, and the total process will take 5 days.

Timeline

• Start date: 2025-07-26
• Primary completion: 2027-06-26
• Completion: 2029-06-26
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: China