Early Phase 1 Lung Cancer Trial, Recruiting NCT05341492 Sponsor: Second Affiliated Hospital of Guangzhou Medical University Condition: Lung Cancer
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Early Phase 1 Lung Cancer Trial, Recruiting

NCT05341492
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You (or your legal guardian) must be willing and able to sign a written consent form before any screening begins
  • You are between 18 and 75 years old and have been diagnosed with advanced lung cancer or triple-negative breast cancer (including cases where targeted therapy treatments have stopped working), confirmed by a tissue or cell sample
  • A tumor test done within the last 3 months has shown that your cancer cells test positive for certain proteins called EGFR and B7H3
  • You have at least one tumor that can be measured on a scan, with scan results available from within the last month
  • Your doctors expect you to live for at least 12 weeks
  • You are generally able to carry out light activity and care for yourself (a standard medical fitness score of 0 or 1)
  • Your liver and kidneys are working well enough, based on recent blood tests showing results within acceptable ranges
  • Your heart is pumping blood effectively, with a heart function score of at least 50% on a heart scan
  • Your blood counts are at acceptable levels (you may qualify even if you needed a blood transfusion to reach these levels)
  • If you are a woman who could become pregnant, or a man, you must agree to use effective contraception for at least 52 weeks after treatment, and until two consecutive tests confirm the treatment cells are no longer in your body

Who may not be able to join:

  • You have poorly controlled high blood pressure, serious heart problems (such as a recent heart attack within the last 6 months, uncontrolled irregular heartbeat, unstable chest pain, or significant heart failure)
  • You have severe liver or kidney problems, or difficulties with consciousness or mental awareness
  • You have received cancer chemotherapy (other than a specific preparatory treatment) within the 14 days before the cell infusion
  • You have taken part in another clinical trial or received another experimental drug within the 14 days before infusion
  • You have had radiotherapy or certain targeted cancer drugs (TKIs) within the 2 weeks before infusion
  • You have active Hepatitis B (confirm with trial site for specific test levels)
  • You test positive for HIV, Hepatitis C, or syphilis
  • You have active tuberculosis, confirmed by certain tests
  • You have a lung condition involving inflammation or scarring of lung tissue (interstitial lung disease or pneumonia)
  • You have a serious, uncontrolled bacterial, viral, or fungal infection (for example, a positive blood infection test within 72 hours of the planned infusion)
  • You have a tumour in or spreading to the brain that is not stable or is causing symptoms, or a tumour that has spread to the sac around the heart with a large build-up of fluid (confirm with trial site for details on exceptions)
  • You currently have, or have previously had, a second different type of cancer — with some exceptions, such as certain fully treated skin cancers, early-stage cervical or breast cancer with no recurrence for at least 3 years, or a previous cancer that was fully removed and has been in complete remission for 5 or more years
  • You are currently pregnant or breastfeeding
  • You have a history of, or currently have, a type of cancer affecting T-cells
  • You have an active autoimmune or inflammatory condition affecting the nervous system (such as Guillain-Barré syndrome or ALS/motor neurone disease)
  • The trial doctor believes, for any other reason, that joining the trial would not be right for you

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 9 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Luo min, PhD, Guangzhou Bio-gene Technology Co., Ltd

Phone: +862039195965

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Second Affiliated Hospital of Guangzhou Medical University
Registry
ClinicalTrials.gov
Start date
1 May 2022
Est. completion
1 May 2030

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Safety by Common Terminology Criteria for Adverse Events (CTCAE) V5.0

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 9 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov