Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Respiratory Distress Syndrome
• Intervention / Treatment: Genetic: CT303

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 Type: Interventional
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Hyesung Jeon; Phone Number: +82-031-260-9059; Email: hs_jeon@gccorp.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 07061
    • Seoul National University Boramae Medical Center
  • Seoul, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥ 19 years old

• Patients who meet the ARDS criteria according to the Berline definition

  1. within 1 week of a known clinical insult or new or worsening respiratory symtoms
  2. Bilateral opacities not fully explained by effusions, loar/lung collapse, or nodules
  3. Respiratory failure not fully explained by cardiac failure or fluid overload
  4. oxygenation corresponding to mild, moderate, severe
• Patients requiring positive pressure ventilation using an endotracheal tube
• Patients or legal representative signed Informed consent form

Exclusion Criteria:

• 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

  1. medical history

     1. Patients who had an organ transplant or bone-marrow transplantation
     2. Patients who had a pneumonectomy
     3. a maligant tumor within 5 years
     4. a deep vein thrombosis or pulmonary embolism with in 6 months
     5. a trauma within 7 days

  2. comorbid condition

     1. Patients with AST or ALT exceeding 5 times the upper limit of the normal range
     2. eGFR ≤ 29mL/min or Patients requiring continuous renal replacement therapy
     3. severe chronic respiratory disease
     4. WHO functional assessment class III/IV pulmonary hypertension
     5. Severe cardiac insufficiency
     6. QTc > 480msec
     7. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm; CT303	Genetic: CT303; Once a time, intravenous injection; CT303 Starting Dose : 1.0*10^6 cells/kg; CT303 Increasing Quantity Dose : 2.0*10^6 cells/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Drug Reaction incidence rate	Evaluate safety through the incidence rate of adverse drug reactions corresponding to criteria for stopping the dose increasing.	Day 0 to Day 28

Collaborators and Investigators

• Sponsor: GC Cell Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2022
• Primary Completion (Actual): February 22, 2023
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: ARDS
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: CT303B101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No