ClinicalTrials.gov record NCT03356808
Antigen-specific T Cells Against Lung Cancer
Multicenter Trial of Cancer Antigen-specific T Cells in the Treatment of Lung Cancer
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1/2 treatment study tests engineered, antigen-specific T cells made from a participant's blood for people with stage III, IV, or relapsed lung cancer. Blood cells are collected, modified and expanded in the lab, then given back by a single intravenous infusion. The study follows participants for safety, for how long the engineered T cells persist, and for tumor response.
What it is studying. The study is testing the feasibility, safety, and anti-tumor activity of engineered antigen-specific T cells (including targets such as MAGE-A1, MAGE-A4, Muc1, GD2, and mesothelin) made from each patient's own blood.
What the researchers hope to learn. Scientific goals are to evaluate feasibility, safety, and preliminary efficacy of antigen-specific engineered T cells in lung cancer, and to learn how long the infused T cells persist and function in the body.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
The purpose of this clinical trial is to assess the feasibility, safety and efficacy of cancer antigen-specific T cells targeting lung cancer. The cancer targeting antigens are identified through immunostaining of patient's cancer specimens. Another goal of the study is to learn more about the persistence and function of the ex vivo manipulated antigen-specific T cells in the body.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- Lung cancer-specific T cells
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy.
- Age: ≥ 18 years and ≤ 80 years.
- 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
- Side Effects of Chemotherapy have subsided.
- Cancer specific antigens are identified and shown to express at high levels (>2+) in malignant tissues by immuno-histochemical staining or flow cytometry.
- Karnofsky/Lansky ≥ 50%.
- Expected survival ≥ 6 weeks.
- Initial hematopoietic conditions with
- neutrophils (ANC) ≥ 1×10\^6/L;
- platelet (PLT) ≥ 1×10\^8/L.
- Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
- serum creatinine ≤ 2×ULN;
- serum bilirubin ≤ 3×ULN;
- AST/ALT ≤ 5×ULN.
- Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures.
Exclusion criteria
- Airway obstruction caused by tumor.
- History of epilepsy or other central nervous system diseases.
- Patients who require systemic corticosteroid or other immunosuppressive therapy.
- History of prolonged or serious heart disease during QT.
- history of serious cyclophosphamide toxicity.
- Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in any immune cell therapy study.
- Inadequate liver and renal function with
- serum creatinine > 2.5 mg/dl;
- serum (total) bilirubin > 2.0 mg/dl;
- AST \& ALT > 3 x ULN.
- Pregnant or lactating females. 9. Serious active infection during screening. 10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
- Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Show the detailed description from the registry
Important Regulatory Notice: This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China. ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities. Lung cancer is a malignancy characterized by uncontrolled cell growth in tissues of the lung. There are two main types of lung cancer, small-cell lung carcinoma (SCLC) and non-small-cell lung carcinoma (NSCLC). In 2012, lung cancer occurred in 1.8 million people and resulted in 1.6 million deaths worldwide. Common treatments include surgery, chemotherapy, and radiotherapy, but in relapsed cancer patients, such treatments often have limited successes. In this study, the participant's peripheral blood mononuclear cells will be collected for antigen-specific T cell preparation, and/or modified using an advanced lentiviral vector system. Then the antigen-specific T cells, called engineered immune effectors (EIEs) or chimeric antigen receptor modified-T cells (CAR T), which can recognize specific molecules that are expressed by the lung cancer cells, are given back to the participant by intravenous infusion. The purpose of this clinical trial is to assess the feasibility, safety and efficacy of T cell immunotherapy targeting single or multiple cancer antigens. The lung cancer antigens include known tumor antigens such as MAGE-A1, MAGE-A4, MucI, GD2, and mesothelin, as well as novel cancer antigens. Another goal of the study is to learn more about the persistence and function of the specific CAR T cells in the body.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If you join, your tumor tissue will be tested for specific cancer antigens (by immunohistochemical staining or flow cytometry), and blood immune cells (peripheral blood mononuclear cells) will be collected by apheresis. The collected T cells will be activated and may be engineered in the lab (including modification using a lentiviral vector) to make antigen-specific or CAR T cells, which are then given back as a single intravenous infusion (about 1×10^6–1×10^7 cells/kg). After infusion you will have safety monitoring and blood tests to measure the engineered cells on Days 7, 14, 21, 28, 60, and 90; tumor response will be assessed using RECIST v1.1 up to one year. The study will record side effects and how long the infused cells persist and function, with primary safety follow-up described for three months.
How the study is structured. This is a non-masked, single-group Phase 1/2 interventional study. Participants donate peripheral blood mononuclear cells (by apheresis) that are activated and engineered ex vivo (using a lentiviral vector system) to create antigen-specific T cells. Participants receive one IV infusion of the engineered T cells (dose listed as 1×10^6 to 1×10^7 cells/kg). Follow-up includes safety monitoring (using CTCAE v4.0) over 3 months, blood tests to measure T-cell expansion and persistence on Days 7, 14, 21, 28, 60, and 90, and tumor assessments by RECIST v1.1 up to 1 year.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Lung Cancer. Does it apply to my diagnosis?
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Gaucher disease
Important dates
- Study start
- Jun 1, 2027 (estimated)
- Primary completion
- Dec 31, 2029 (estimated)
- Study completion
- Dec 31, 2030 (estimated)
- Target enrollment
- 20 participants (estimated)
- Last updated on registry
- Aug 26, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Shenzhen Geno-Immune Medical Institute
- Principal investigator
- Lung-Ji Chang, President
Shenzhen Geno-Immune Medical Institute
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Lung-Ji Chang, PhD 📞 +86 0755-86573763 ✉ c@szgimi.org
Participating sites (1)
- Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000 · China
- Lung-Ji Chang, PhD · +86 0755-86573763 · c@szgimi.org
Terms used on this page · explanations by MedicalUpdates.ai
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- Karnofsky
- A scale from 100 (no complaints) down to 0 that describes how well a person can carry out daily activities. Studies often require a minimum score.
- ANC
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
- ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- corticosteroid
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- investigational drug
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- during screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- sponsor
- The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
- chimeric antigen receptor
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials