Clinical trial · Interventional
Antigen-specific T Cells Against Lung Cancer
Multicenter Trial of Cancer Antigen-specific T Cells in the Treatment of Lung Cancer
NCT03356808CI-TRIAL-00123984not yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lung cancer-specific T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lung cancer-specific T cells
- description
- Peripheral blood mononuclear cells (PBMCs) of patients, who have cancer antigen identified lung cancer, will be obtained through apheresis, and T cells will be activated and ex vivo engineered.
- interventionNames
- Biological: Lung cancer-specific T cells
Primary outcomes (1)
- measure
- Safety of engineered T cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events
- timeFrame
- 3 months
- description
- Physiological parameter (measuring cytokine response)
Secondary outcomes (2)
- measure
- Persistence and proliferation of engineered antigen-specific T cells in patients
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy. 2. Age: ≥ 18 years and ≤ 80 years. 3. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy. 4. Side Effects of Chemotherapy have subsided. 5. Cancer specific antigens are identified and shown to express at high levels (\>2+) in malignant tissues by immuno-histochemical staining or flow cytometry. 6. Karnofsky/Lansky ≥ 50%. 7. 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. 10\. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures. Exclusion Criteria: 1. Airway obstruction caused by tumor. 2. History of epilepsy or other central nervous system diseases. 3. Patients who require systemic corticosteroid or other immunosuppressive therapy. 4. History of prolonged or serious heart disease during QT. 5. history of serious cyclophosphamide toxicity. 6. 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. 8\. 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. 11\. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
References
Publications (0)
Data not yet available
No reference posted for this study.