Clinical trial · Interventional
Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer
An Open, 3+3 Design With Dose De-escalation, Single-center, Phase 1 Trial to Evaluate Tolerabiility and Safety of Intravenously Administered CBT101, an Autologous Natural Killer Cell, in Patients Who Underwent Curative Surgery and Adjuvant Therapy for Solid Cancer
NCT04557306CI-TRIAL-00075793completedPhase 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 objective of the study is to evaluate tolerability and safety of CBT101 in patients who underwent curative surgery and adjuvant therapy for solid 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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBT101 cells, every 2 weeks | Biological | — | UNRESOLVED |
| CBT101 cells, every 4 weeks | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CBT101 q2w
- description
- CBT101 cells, every 2 weeks
- interventionNames
- Biological: CBT101 cells, every 2 weeks
- type
- EXPERIMENTAL
- label
- CBT101 q4w
- description
- CBT101 cells, every 4 weeks
- interventionNames
- Biological: CBT101 cells, every 4 weeks
Primary outcomes (1)
- measure
- Dose limiting toxicity (DLT)
- timeFrame
- 29 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male and female adults aged 19 years and older 2. Patients with solid tumors as below (1) histologically or cytologically confirmed solid tumors (2) 4 - 12 weeks of last adjuvant therapy after radical operations and adjuvant therapy 3. Life expectancy 6 months 4. Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1 Exclusion Criteria: 1. History of leptomeningeal carcinomatosis or spinal cord compression 2. History of peritoneal carninomatosis 3. Hemoglobine less than 9.0g/dL 4. Absolute Neutrophil Count (ANC) less than 1.5x10\^3/mm\^3 5. Platelet count less than 75x10\^9/L 6. Total bilitbinn grater than 1.5 times te upper limit of normal 7. Alanine amino transferase (ALT) greater than 3 times the upper limit of normal 8. Alanine phospatase (ALP) greater than 2.5 times the upper limit of normal 9. Uncontrolled hypertension 10. Intensive insuline therapy 11. Active infectious disease 12. Patients with hypersensitivity history or allergy to investigational product 13. Pregmant of lactating woman 14. Patients who have participated in another clinical trials witin 30 days before the start of this clinical trial 15. Patients judged to be inappropriate for this study by the investigator with other reasons
References
Publications (0)
Data not yet available
No reference posted for this study.