Clinical trial · Interventional
Clinical Efficacy and Safety of NK and NKT Cells Infusion in Patients With Non Small Cell Lung Cancer
A Phase 1/2 Safety and Efficacy Study of Natural Killer and Natural Killer T Cell Immunotherapy in Patients With Non Small Cell Lung Cancer
NCT03198923CI-TRIAL-00029655unknownPhase 1ClinicalTrials.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 study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based immunotherapy in subjects with non small cell lung cancer.
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| natural killer and natural killer T cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- natural killer and natural killer T cell
- description
- The eligible patients are infused with ten doses of (2-2.5)x10\^9 NK and NKT cells in one course of treatment.
- interventionNames
- Biological: natural killer and natural killer T cell
Primary outcomes (2)
- measure
- The incidence of adverse events following infusion of NK and NKT cells
- timeFrame
- 30 days post-infusion
- measure
- Overall Survival (OS)
- timeFrame
- Approximately 3 years
Secondary outcomes (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 to 75 years, Male or Female * Histological or cytologically diagnosis of non-small cell lung cancer * Recurrent or metastatic after surgical treatment * The pathology must be an assessable disease, signal lesion not exceeding 3 cm in diameter (measurable by CT scan or MRI)，number of Lymph node metastasis is less than 5 * Refractory to standard treatments (e.g., chemotherapy, radiation, etc.) * No chemotherapy and radiation therapy to be planned recently * Patients must have a Karnofsky performance status greater than or equal to 70% * Life expectancy greater than 3 months * Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure * Agree that progress of the disease must be radiographically measurable by computerized tomography (CT) scanning technique or magnetic resonance imaging (MRI) (per RECIST1.1 criteria) * Agrees to participate in long-term follow-up for up to 3 years, if received NK and NKT infusion * Laboratory values within the following ranges prior to receiving treatment of study agent: Peripheral blood cells \>3×10\^9 /L; Number of lymphocytes \>1.0×10\^9 /L; Lymphocyte ratio \>18%; INR\<1.5. Exclusion Criteria: * Patients with no surgical treatment * Patients within concurrent chemotherapy or radiation * Known or suspected allergy to the investigational agent or any agent given in association with this trial * Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment * History of immunodeficiency disease or autoimmune disease * Patients with chronic disease which is undergoing immune reagents or hormone therapy * Serious infections requiring antibiotics, bleeding disorders * Previous bone marrow or stem cell transplant, or organ allograft * Concurrent other medical condition that would prevent the patient from undergoing protocol-based therapy * Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent * Pregnant or breast-feeding patients * Lack of availability of a patient for immunological and clinical follow-up
References
Publications (0)
Data not yet available
No reference posted for this study.