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

NCT07031011 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-06-22

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • jiuwei cui

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-01-31
Completion
2027-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07031011 on ClinicalTrials.gov