- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557306
Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer
April 5, 2024 updated by: CHABiotech CO., Ltd
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chan Kim
- Phone Number: +82 31 780 5000
- Email: larrel80@gmail.com
Study Locations
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
- CHA Bundang Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBT101 q2w
CBT101 cells, every 2 weeks
|
CBT101 cells, every 4 weeks
|
Experimental: CBT101 q4w
CBT101 cells, every 4 weeks
|
CBT101 cells, every 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose limiting toxicity (DLT)
Time Frame: 29 days
|
Dose limiting toxicity (DLT)
|
29 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease-free survival rate (DFS)
Time Frame: 6 months
|
Disease-free survival rate (DFS)
|
6 months
|
Oerall survival rate (OS)
Time Frame: 6 months
|
Oerall survival rate (OS)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chan Kim, CHA Bundang Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2020
Primary Completion (Actual)
October 26, 2021
Study Completion (Actual)
October 26, 2021
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 21, 2020
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- CBT101_P1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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