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
1 other identifier
interventional
6
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2020
CompletedFirst Posted
Study publicly available on registry
September 21, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedApril 8, 2024
February 1, 2024
1.1 years
September 15, 2020
April 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT)
29 days
Secondary Outcomes (2)
Disease-free survival rate (DFS)
6 months
Oerall survival rate (OS)
6 months
Study Arms (2)
CBT101 q2w
EXPERIMENTALCBT101 cells, every 2 weeks
CBT101 q4w
EXPERIMENTALCBT101 cells, every 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496, South Korea
Study Officials
- PRINCIPAL INVESTIGATOR
Chan Kim
CHA Bundang Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2020
First Posted
September 21, 2020
Study Start
September 21, 2020
Primary Completion
October 26, 2021
Study Completion
October 26, 2021
Last Updated
April 8, 2024
Record last verified: 2024-02