Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Solid Tumor

Intervention / Treatment
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* Biological: CBT101 (2-6 x 10^9 cells), every 2 weeks
* Biological: CBT101 (2-6 x 10^9 cells), every 4 weeks


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged 19 years and older 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 Life expectancy 6 months Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1 Exclusion Criteria: History of leptomeningeal carcinomatosis or spinal cord compression History of peritoneal carninomatosis Hemoglobine less than 9.0g/dL Absolute Neutrophil Count (ANC) less than 1.5x10^3/mm^3 Platelet count less than 75x10^9/L Total bilitbinn grater than 1.5 times te upper limit of normal Alanine amino transferase (ALT) greater than 3 times the upper limit of normal Alanine phospatase (ALP) greater than 2.5 times the upper limit of normal Uncontrolled hypertension Intensive insuline therapy Active infectious disease Patients with hypersensitivity history or allergy to investigational product Pregmant of lactating woman Patients who have participated in another clinical trials witin 30 days before the start of this clinical trial Patients judged to be inappropriate for this study by the investigator with other reasons

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT101 q2w<br>CBT101 (2-6 x 10^9 cells), every 2 weeks | Biological: CBT101 (2-6 x 10^9 cells), every 2 weeks<br>* CBT101 (2-6 x 10^9 cells), every 4 weeks<br>|
| Experimental: CBT101 q4w<br>CBT101 (2-6 x 10^9 cells), every 4 weeks | Biological: CBT101 (2-6 x 10^9 cells), every 4 weeks<br>* CBT101 (2-6 x 10^9 cells), every 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose limiting toxicity (DLT) |  | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival rate (DFS) |  | 6 months | 
| Oerall survival rate (OS) |  | 6 months |