Solid TumorPhase 1NCT04557306
Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer
A Phase 1 study testing CBT101 cells, every 2 weeks and CBT101 cells, every 4 weeks in people with Solid Tumor, run by CHABiotech CO., Ltd at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- CBT101 cells, every 2 weeks and CBT101 cells, every 4 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Sep 2020to 26 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
About this study
Official title: 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
- Conditions
- Solid Tumor
- Being tested
- CBT101 cells, every 2 weeks, CBT101 cells, every 4 weeks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT101 cells, every 2 weeksBiological
CBT101 cells, every 4 weeks
CBT101 cells, every 4 weeksBiological
CBT101 cells, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| CBT101 q2w | Experimental | CBT101 cells, every 2 weeks Receives: Biological: CBT101 cells, every 2 weeks |
| CBT101 q4w | Experimental | CBT101 cells, every 4 weeks Receives: Biological: CBT101 cells, every 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Dose limiting toxicity (DLT)
Measured: 29 days
Secondary outcomes (2)
Disease-free survival rate (DFS)
Disease-free survival rate (DFS)
Measured: 6 months
Oerall survival rate (OS)
Oerall survival rate (OS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start21 Sep 2020
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHABiotech CO., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chan Kim, Principal investigator, CHA Bundang Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557306
- Sponsor's protocol ID
- CBT101_P1
- Status last verified
- Feb 2024
- First submitted
- 15 Sep 2020
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04557306
- Acronym / sponsor ID
- CBT101_P1
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- CHABiotech CO., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT101 q2w | Experimental | Biological: CBT101 cells, every 2 weeksCBT101 cells, every 2 weeks |
| CBT101 q4w | Experimental | Biological: CBT101 cells, every 4 weeksCBT101 cells, every 4 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT101 cells, every 2 weeksCBT101 cells, every 4 weeks | Biological | CBT101 q2w |
| CBT101 cells, every 4 weeksCBT101 cells, every 4 weeks | Biological | CBT101 q4w |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: 29 days
Dose limiting toxicity (DLT)
2 secondary outcomes
Disease-free survival rate (DFS)
Time frame: 6 months
Oerall survival rate (OS)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
Related trials for Solid Tumor
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chan Kim principal investigator
CHA Bundang Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBT101 cells, every 2 weeks and CBT101 cells, every 4 weeks in people with Solid Tumor, run by CHABiotech CO., Ltd at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: 29 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.