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

Sponsor
GC Cell Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05238532
Collaborator
(none)
8
3
1
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Study Details

Study Description

Brief Summary

Evaluate the safety, tolerability, efficacy and pharmacodynamics&pharmacokinetic properties of CT303 in patients with ARDS.

Condition or Disease Intervention/Treatment Phase
  • Genetic: CT303
Phase 1

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

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 26, 2022
Anticipated Primary Completion Date :
May 29, 2023
Anticipated Study Completion Date :
Oct 18, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  2. Patients who had an organ transplant or bone-marrow transplantation

  3. Patients who had a pneumonectomy

  4. a maligant tumor within 5 years

  5. a deep vein thrombosis or pulmonary embolism with in 6 months

  6. a trauma within 7 days

  7. comorbid condition

  8. Patients with AST or ALT exceeding 5 times the upper limit of the normal range

  9. eGFR ≤ 29mL/min or Patients requiring continuous renal replacement therapy

  10. severe chronic respiratory disease

  11. WHO functional assessment class III/IV pulmonary hypertension

  12. Severe cardiac insufficiency

  13. QTc > 480msec

  14. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul national university hospital Seoul Korea, Republic of 03080
2 Seoul national university boramae medical center Seoul Korea, Republic of 07061
3 Seoul National University Bundang Hospital Seoul Korea, Republic of 13620

Sponsors and Collaborators

  • GC Cell Corporation

Investigators

  • Principal Investigator: Young-Jae Cho, MD, MPH, PhD, Seoul National University Bundang Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GC Cell Corporation
ClinicalTrials.gov Identifier:
NCT05238532
Other Study ID Numbers:
  • CT303B101
First Posted:
Feb 14, 2022
Last Update Posted:
Mar 24, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GC Cell Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 24, 2022