Acute Respiratory Distress SyndromePhase 1NCT05238532
Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS
A Phase 1 study testing CT303 in people with Acute Respiratory Distress Syndrome, run by GC Cell Corporation at 3 sites in South Korea.
Trial summary
Evaluate the safety, tolerability, efficacy and pharmacodynamics\&pharmacokinetic properties of CT303 in patients with ARDS. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- CT303
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 26 Jan 2022to 22 Feb 2023
- 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
- ≥ 19 years old
- Patients who meet the ARDS criteria according to the Berline definition
- within 1 week of a known clinical insult or new or worsening respiratory symtoms
- Bilateral opacities not fully explained by effusions, loar/lung collapse, or nodules
- Respiratory failure not fully explained by cardiac failure or fluid overload
- oxygenation corresponding to mild, moderate, severe
- Patients requiring positive pressure ventilation using an endotracheal tube
- Patients or legal representative signed Informed consent form
Who cannot join
- Greater than 96 hours since first meeting ARDS criteria
- Patients who was previously administered mesenchymal stem cell therapy products or other cell therapy products
- Patients with the following medical history or comorbid condition
- medical history
- Patients who had an organ transplant or bone-marrow transplantation
- Patients who had a pneumonectomy
Show all 25Show fewer
- a maligant tumor within 5 years
- a deep vein thrombosis or pulmonary embolism with in 6 months
- a trauma within 7 days
- comorbid condition
- Patients with AST or ALT exceeding 5 times the upper limit of the normal range
- eGFR ≤ 29mL/min or Patients requiring continuous renal replacement therapy
- severe chronic respiratory disease
- WHO functional assessment class III/IV pulmonary hypertension
- Severe cardiac insufficiency
- QTc > 480msec
- chronic underlying diseases
- viral hepatitis type B or type C, or positive HIV test
- Patients using extracorporeal life support devices or high-frequency oscillatory ventilation
- Moribund patients expected to die within 48 hours
- Patients who refuse or are likely to refuse life-sustaining treatment
- Fertile women or men who disagree a continence and a contraception
- Patients with a history of hypersensitivity reaction
- Patients participating in clinical trials within 4 weeks
- Patients determined by the investigator to be inappropriate to participate in this clinical trial
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul national university hospital
Seoul, 03080
Seoul national university boramae medical center
Seoul, 07061
Seoul National University Bundang Hospital
Seoul, 13620
About this study
Official title: A Multi-center, Open-label Dose-escalation and Dose-finding Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Acute Respiratory Distress Syndrome
Evaluate the safety, tolerability, efficacy and pharmacodynamics\&pharmacokinetic properties of CT303 in patients with ARDS.
Read the detailed description
This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial.
The primary purpose is to evaluate the safety and tolerability of CT303 and the Secondary purpose is to evaluate the efficacy of CT303 in patients with ARDS. And the exploratory purpose is to evaluate pharmacodynamics properties pharmacokinetic properties of CT303 in patients with ARDS.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- CT303
- Keywords
- ARDS
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT303Genetic
Once a time, intravenous injection
- CT303 Starting Dose : 1.0*10^6 cells/kg
- CT303 Increasing Quantity Dose : 2.0*10^6 cells/kg
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | CT303 Receives: Genetic: CT303 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Drug Reaction incidence rate
Evaluate safety through the incidence rate of adverse drug reactions corresponding to criteria for stopping the dose increasing.
Measured: Day 0 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start26 Jan 2022
- Primary completion22 Feb 2023
- Study completion22 Feb 2023
Why it stopped: Difficulties in recruiting Subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GC Cell Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Jae Cho, MD, MPH, PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238532
- Sponsor's protocol ID
- CT303B101
- Status last verified
- Mar 2023
- First submitted
- 3 Feb 2022
- Last updated
- 4 Apr 2023
- 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label Dose-escalation and Dose-finding Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT05238532
- Acronym / sponsor ID
- CT303B101
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficulties in recruiting Subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GC Cell CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 22 Feb 2023 (actual)
- Study completion
- 22 Feb 2023 (actual)
- First posted
- 14 Feb 2022 (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.
Evaluate the safety, tolerability, efficacy and pharmacodynamics\&pharmacokinetic properties of CT303 in patients with ARDS.
Detailed description
This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial.
The primary purpose is to evaluate the safety and tolerability of CT303 and the Secondary purpose is to evaluate the efficacy of CT303 in patients with ARDS. And the exploratory purpose is to evaluate pharmacodynamics properties pharmacokinetic properties of CT303 in patients with ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Genetic: CT303CT303 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 19 years old
- Patients who meet the ARDS criteria according to the Berline definition
- Patients requiring positive pressure ventilation using an endotracheal tube
- Patients or legal representative signed Informed consent form
Key exclusion criteria (25 listed)
- Greater than 96 hours since first meeting ARDS criteria
- Patients who was previously administered mesenchymal stem cell therapy products or other cell therapy products
- Patients with the following medical history or comorbid condition
- viral hepatitis type B or type C, or positive HIV test
- Patients using extracorporeal life support devices or high-frequency oscillatory ventilation
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 |
|---|---|---|
| CT303Once a time, intravenous injection * CT303 Starting Dose : 1.0*10^6 cells/kg * CT303 Increasing Quantity Dose : 2.0*10^6 cells/kg | Genetic | Single Arm |
Primary outcome
Adverse Drug Reaction incidence rate
Time frame: Day 0 to Day 28
Evaluate safety through the incidence rate of adverse drug reactions corresponding to criteria for stopping the dose increasing.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
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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.
Young-Jae Cho, MD, MPH, PhD principal investigator
Seoul National University Bundang Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CT303 in people with Acute Respiratory Distress Syndrome, run by GC Cell Corporation at 3 sites 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 8 inclusion and 25 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: withdrawn, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Adverse Drug Reaction incidence rate (time frame: Day 0 to Day 28). 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 4 Apr 2023.