NCT07031011

PD-1-M1-NK Cells in the Treatment of Advanced Gastric or Colorectal Cancer

An Early Clinical Study to Investigate the Safety, Pharmacokinetics, and Efficacy of PD-1-M1-NK Cells (YC-T-001) in Patients With Advanced Gastric or Colorectal Cancer Failed or Intolerant to at Least Second-line Therapy

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: jiuwei cui · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an Early Clinical Study to Investigate the Safety, Pharmacokinetics, and Efficacy of PD-1-M1-NK Cells (YC-T-001) in Patients with Advanced Gastric or Colorectal Cancer Failed or Intolerant to at Least Second-line Therapy.

Conditions

• Advanced Gastric or Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	PD-1-M1-NK Cells	At dose escalation stage, four dose groups were initially determined: 5×106CAR NK cells/kg, 1×107CARNK cells/kg, 2×107CARNK cells/kg, and 5×107 CARNK cells/kg. Administration cycle: In Cycle 1 (C1), the drug was administered once on days 1, 4, 7, 10 and 13 respectively. A complete cycle was formed by five consecutive administrations. For subjects with stable, partial response or complete response in the tumor assessment at the first time in week 4, the treatment in Cycle 2 will continue subsequently. In Cycle 2, the drug was administered once every two weeks (Q2W: D14±7 days and D28±7 days).

Timeline

• Start date: 2025-06-30
• Primary completion: 2027-01-31
• Completion: 2027-06-30
• First posted: 2025-06-22
• Last updated: 2025-06-22

Locations

1 site across 1 country: China