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NOT YET RECRUITING
NCT07031011
PHASE1

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

Sponsor: jiuwei cui

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

22

Start Date

2025-06-30

Completion Date

2027-06-30

Last Updated

2025-06-22

Healthy Volunteers

No

Interventions

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).

Locations (1)

Cancer Center, The First Affiliated Hospital of Jilin University

Changchun, Jilin, China