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RecruitingEarly Phase 1NCT05060796

Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC

A Single-arm, Open-label, Phase I Study to Evaluate the Safety and Efficacy of CXCR5 Modified EGFR Chimeric Antigen Receptor Autologous T Cells in EGFR-positive Patients With Advanced Non-small Cell Lung Cancer

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

11 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

This study is a single arm, open-label, intravenous infusion of Anti- Epidermal growth factor receptor (EGFR) Chimeric Antigen Receptor (CAR) T cells modified by C-X-C Chemokine receptor type 5 (CXCR 5) in patients with advanced adult non-small cell lung cancer (NSCLC).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of cell therapy (CAR-T cells modified with CXCR5) that is engineered to target EGFR, a protein found on many lung cancer cells. It is designed for patients with advanced non-small cell lung cancer (NSCLC) whose standard treatments have stopped working. **You may be eligible if...** - You are aged 18–75 with confirmed advanced NSCLC whose cancer progressed on standard treatment including targeted therapies (TKIs) - Your tumor tests positive for EGFR expression (2+ or higher) and shows CXCL13 factor positivity ≥ 10% - You are in good health overall (ECOG 0–1) with adequate organ function **You may NOT be eligible if...** - Your tumor does not have the required EGFR or CXCL13 markers - You have active autoimmune disease or are on immunosuppressants - You have uncontrolled infections, severe organ dysfunction, or other serious conditions 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

BIOLOGICALCXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells

The first dose group: 0.5 × 10\^6/kg CAR positive T cells; The second dose group: 1.58 × 10\^6/ kg CAR positive T cells; The third dose group: 5 × 10\^6/kg CAR positive T cells. The above dose allows a 20 % error; For subjects with body weight greater than 60 kg, the number of cells can only be calculated according to 60 kg of body weight.

Locations(1)

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

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NCT05060796

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