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

Phase 1

Withdrawn

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Genetic: CT303

• Registration Number: NCT05238532
• Lead Sponsor: GC Cell Corporation

Brief Summary

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 Timeline

• Study Start: 2022-01-26
• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-03
• Study First Posted: 2022-02-14
• Primary Completion: 2023-02-22
• Study Completion: 2023-02-22
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	CT303	CT303

Primary Outcome Measures

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

Trial Locations

Locations (3)

Seoul national university boramae medical center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul national university hospital; 🇰🇷 Seoul, Korea, Republic of