Clinical trial · Interventional
Safety Study of Cord Blood-derived Cytokine-induced Killer Cells in Patients With Solid Tumor After Radical Resection
Phase 1 Study of Cord Blood-derived Cytokine-induced Killer Cells in Patients With Solid Tumor After Radical Resection
- 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)
Cytokine-induced killer (CIK) cells are a heterogeneous subset of ex-vivo expanded T lymphocytes which present a mixed T-NK phenotype and are endowed with a major histocompatibility complex-unrestricted antitumor activity. Radical surgery is a good therapy for patients with solid tumor.However, tumor relapse is still a risk for those patients. Our hypothsis is that cytokine induced killer cells maybe decrease the recurrence rate. The purpose of this study is to evaluate the safety and tolerability of cord blood-derived cytokine induced killer cells in patients with solid tumor following radical resection.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytokine induced killer cell | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- cytokine induced killer cell
- description
- The eligible patients are infused a single dose of 8x10\^9 CIK cells.
- interventionNames
- Biological: cytokine induced killer cell
- type
- NO_INTERVENTION
- label
- Control
- description
- The eligible patients are followed up for 30 days without any treatment.
Primary outcomes (1)
- measure
- The incidence of adverse events following infusion of cord blood-derived cytokine-induced killer cells.
- timeFrame
- 30 days post-infusion
- description
- The primary outcome measures for safety will include the incidence of fever,chill,rash and Graft-versus-Host Disease (GVHD).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients over 18 years of age. * Patients who give written informed consent. * Patients with solid tumor already had radical resection * Definition of radical resection in this study: * All tumors were moved out, with a clean resection margin. * No distance metastasis. * No major post-operative complication. * Without any anti-cancer medication within the past 15 days. * The following laboratory parameters: Platelet count \>= 70 x 109/L; Hemoglobin \>= 8.5 g/dL; Albumin \>= 3.5 g/dL; Total bilirubin \<= 25umol/L; Alanine transaminase (ALT) and AST \<= 2.5 x upper limit of normal; Serum creatinine \<= 1.5 x the upper limit of normal; Prothrombin time (PT) \<= 3 seconds above control. Exclusion Criteria: * History of cardiac disease. * Active clinically serious infections * Known history of human immunodeficiency virus (HIV) infection * Known Central Nervous System tumors including metastatic brain disease. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * History of organ allograft. * Known or suspected allergy to the investigational agent or any agent given in association with this trial. * Pregnant or breast-feeding patients. * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
References
Publications (0)
Data not yet available