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

NCT07096882 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-07-31

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cytocraft Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-07-26
Primary Completion
2027-06-26
Completion
2029-06-26

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07096882 on ClinicalTrials.gov