Clinical trial · Interventional
A Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy
A Phase II Study to Evaluate the Safety and Efficacy of Ex Vivo Expanded Autologous Immune Killer Cells (IKC) in Stage IV Non-small Cell Lung Cancer (NSCLC) in Patients Who Failed Chemotherapy or Target Therapy
NCT03499834CI-TRIAL-00044700IVY03completedPhase 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)
In this study, whole blood is drawn from the patient to be used to grow Immune Killer Cells (IKC). After proliferation, the IKC will be infused back into the patient to treat the cancer for a total of 24 weekly treatments. Possible adverse reaction can include slight fever and headache.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer (NSCLC) Stage IV | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immune Killer Cells (IKC) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Group
- description
- 26 patients who has successfully undergone the screening criteria will be enrolled for treatment. Immune Killer Cells (IKC) will be administered through Intravenous Injection (I.V.) Frequency: One injection per week, twenty-four injections on-treatment
- interventionNames
- Biological: Immune Killer Cells (IKC)
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- 6 months
- description
- The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse
Secondary outcomes (2)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety]
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age≧20 years old 2. Life expectancy≧3 months 3. Eastern Cooperative Oncology group (ECOG) score 0\~2 4. Cytologically-or histologically-confirmed non-small cell lung cancer（NSCLC) 5. Patients with clinical TNM classification of Malignant Tumours (TNM) stage IV... Exclusion Criteria: 1. Patients with history of cardiovascular disease, including uncontrolled hypertension, congestive heart failure, myocardial infarction, angina pectoris, coronary artery disease, uncontrolled arrhythmia , previous history of encephalopathy within the past six months of screening period 2. Patients with HIV, HTLV or active tuberculosis 3. Women who are pregnant or breast-feeding 4. Patients with drug or other substance abuse 5. Patients with any other major disease, serious organ failure or patients unfit for participating in the trial (by the investigator's judgment)
References
Publications (1)
- DERIVEDTseng YH, Ho CL, Chian CF, Chiang CL, Chao HS, Tsai CL, Perng WC, Hsiao CF, Chuang MH, Ko KH, Cheng YC, Chen SJ, Wang CJ, Chen YM. Immune killer cells treatment for previously treated stage IV NSCLC patients. Sci Rep. 2024 Aug 21;14(1):19374. doi: 10.1038/s41598-024-69587-x. PMID 39169058