RecruitingPhase 2NCT07330050

WAST Cell-Docetaxel Combination Therapy in PD-1 Inhibitor-Resistant Advanced NSCLC

Phase II Clinical Trial Evaluating Whole Agonist-Stimulated T (WAST) Cells in Combination With Docetaxel as a Second-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC) Resistant to PD-1 Inhibitors


Sponsor

Tianjin Medical University Cancer Institute and Hospital

Enrollment

31 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective Phase II study aims to evaluate the preliminary efficacy and safety of WAST cells combined with docetaxel as second-line therapy in patients with advanced NSCLC resistant to PD-1 inhibitors.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of WAST cells (a type of immune cell therapy) plus docetaxel (a chemotherapy drug) for patients with advanced non-small cell lung cancer (NSCLC) whose disease has stopped responding to first-line immunotherapy (PD-1 inhibitors). The goal is to see if this combination can overcome resistance and improve outcomes. **You may be eligible if...** - You have advanced NSCLC confirmed by biopsy - Your cancer has progressed after receiving a PD-1 inhibitor as first-line treatment - You have at least one measurable tumor larger than 1 cm - You are in good general health (ECOG performance status 0 or 1) - Your blood counts, liver, and kidney function are within acceptable ranges - Your expected survival is greater than 3 months **You may NOT be eligible if...** - Your lung cancer has not progressed on prior PD-1 immunotherapy - You do not have measurable tumors on imaging - Your general health is too poor (ECOG above 1) - Your blood counts or organ function are outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALWhole Agonist-Stimulated T (WAST) cells injection

WAST cells (≥4.0 × 10⁹ cells), intravenous infusion, d14, Q3W for 4 cycles.

DRUGDocetaxel

75 mg/m², intravenous infusion, day 1, Q3W.


Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

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NCT07330050


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