Trial intelligence / Profile preview

Dual-target CAR-NK Cells in Advanced/Metastatic NSCLC

NCT07641023Phase 2

Key facts

Status: Recruiting
Start: Mar 2026
Primary completion: Mar 2027
Countries: 1
Sponsor: Biotech Pharmaceutical

Drugs: EB-DT-CAR-NK
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label trial of EB-DT-CAR-NK in non-small cell lung cancer (NSCLC) (3 arms), sponsored by Biotech Pharmaceutical. Primary endpoints: Dose-limiting toxicities at 28 days, Recommended Phase 2 dose at 28 days and 1 more. Started Mar 2026; status: recruiting.

Design

3 arms

Study design: Non-randomizedOpen-label

EB-DuoNK-MSLN/EGFR
Participants with tumors co-expressing MSLN and EGFR receive lymphodepletion followed by EB-DuoNK-MSLN/EGFR infusion.
EB-DuoNK-MSLN/HER2
Participants with tumors co-expressing MSLN and HER2/ERBB2 receive lymphodepletion followed by EB-DuoNK-MSLN/HER2 infusion.
EB-DuoNK-EGFR/HER2
Participants with tumors co-expressing EGFR and HER2/ERBB2 receive lymphodepletion followed by EB-DuoNK-EGFR/HER2 infusion.

Who it enrols

Patients with advanced/metastatic NSCLC (Stage IIIB/IIIC or IV) who progressed on standard therapy (platinum + ICI) and have tumors co-expressing at least two of MSLN, EGFR, or HER2/ERBB2. Excludes patients with active CNS metastases, recent prior cell therapy, or active infections.

Endpoints

Primary

Dose-limiting toxicities28 days
Recommended Phase 2 dose28 days
Objective response rate6 months

Secondary

Duration of response12 months
Disease control rate6 months
Progression-free survival12 months

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