Clinical trial · Interventional
Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor
NCT03551795CI-TRIAL-00058344completedPhase 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)
Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells.The hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may resist inflection and decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of tuberculosis with malignant solid tumor by infusing of iNKT cells.
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 |
|---|---|---|---|
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infusion of iNKT cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment
- description
- The eligible patient receive the experimental infusion of iNKT cells.
- interventionNames
- Biological: Infusion of iNKT cells
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 4 months post-infection
- description
- Change of target focus confirmed by CT or MRI
Secondary outcomes (1)
- measure
- Incidence of adverse events related to the infusion of cells
- timeFrame
- 28 days post-infusion
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histological or cytologically diagnosis of tuberculosis with malignant solid tumor * Patients' tumor tissue (formalin-fixed, paraffin-embedded) must be sufficient for diagnosis of cancer by a certified Laboratory of Pathology * Laboratory values within the following ranges prior to receiving treatment of study agent: Hemoglobin≧8.0 g/dL, Neutrophils count≧1E9/L, Lymphocytes count≧lower limit of institutional normal, Platelet count≧50E9/L, Serum creatinine≦2.0 mg/dL, Serum bilirubin≦2 x upper limit of institutional normal, AST/ALT≦2 x upper limit of institutional normal * No dyspnea at rest. Oxygen saturation ≥90% on room air * No genetic disease * Fertile females/males must consent to use contraceptives during participation of the trial. Women of child bearing potential must have a negative pregnancy test prior to receiving treatment of study agent within 7 days * Patients must have a Karnofsky performance status greater than or equal to 80% * Able and willing to give witnessed, written informed consent form prior to receiving any study related procedure * Agrees to participate in long-term follow-up for up to 1 years, if received NKT infusion Exclusion Criteria: * Organ dysfunction,such as significant cardiovascular disease, myocardial infarction within the past six months, unstable angina, coronary angioplasty within the past six months, uncontrolled atrial or ventricular cardiac arrhythmias; Child-Pugh C; Renal function failure or uremia; Respiratory failure; Disturbance of consciousness; Renal failure. * Suffering from lymphoma or leukemia * Serious infections requiring antibiotics, bleeding disorders * Patients with myelodysplastic syndrome (MDS) * History of immunodeficiency disease or autoimmune disease * Positive HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C PCR within 21 days prior to enrollment * Within concurrent chemotherapy * 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 * Can't give informed consent * Lack of availability for follow-up assessment
References
Publications (0)
Data not yet available
No reference posted for this study.