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

March 3, 2022 updated by: GC Cell Corporation

An Open-label, Dose-escalation, Phase 1 Trial to Investigate the Safety, Tolerability, and Efficacy After Single- and Multiple-dose Administration of CT303 in Patients With Moderate to Severe Plaque Psoriasis

Investigate the Safety, Tolerability, Efficacy and pharmacodynamics properties of CT303 in patients with moderate to severe plaque psoriasis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 safety and efficacy of CT303 in patients with moderate to severe plaque psoriasis.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 13496
        • Recruiting
        • CHA Medical School Bundang CHA Medical Center
        • Contact:
        • Principal Investigator:
          • Donghyun Kim
      • Pusan, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
        • Principal Investigator:
          • Byungsoo Kim
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Seongjin Jo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  1. ≥ 19 years old
  2. Plaque psoriasis diagnosed before ≥ 6 months who did not show a sufficient response to one or more of the traditional systemic treatments or require change of treatment due to intolerance
  3. Have moderate to severe plaque psoriasis as defined by PASI score ≥ 12, BSA ≥ 10% and sPGA score ≥ 3
  4. Patients who have voluntarily decided to participate in the study and signed the informed consent form

Exclusion Criteria:

  1. Guttate psoriasis, erythrodermic psoriasis, palmoplantar psoriasis, drug-induced psoriasis, and inverse psoriasis
  2. History of treatment with cell therapy products including but not limited to mesenchymal stem cells
  3. Have hypersensitivity, or medical history of clinically significant hypersensitivity, to the IP or its excipients
  4. Current or history of cardiovascular diseases
  5. Clinically significant hemorrhagic diseases, or gastrointestinal, respiratory, endocrinal, musculoskeletal, or neuropsychiatric disorders that are deemed by the investigator to be a potential threat to the safety of the subject due to study participation
  6. Use of anticoagulants within 7 days prior to IP administration

  7. Following treatment history for psoriasis

    • Use of topical therapy within the past 2 weeks
    • Use of phototherapy and/or systemic therapy within the past 4 weeks
    • Use of biologics within the past 4 to 24 weeks
  8. Severe infection or other uncontrolled active infectious diseases requiring administration of systemic antibiotics, antivirals, etc. within 4 weeks prior to IP administration
  9. Systemic or local inflammatory diseases requiring systemic anti-inflammatory treatment within 4 weeks prior to IP administration
  10. Received or are scheduled to receive a live/live attenuated viral/bacterial vaccination within 12 weeks prior to IP administration (within 12 months for BCG vaccines)
  11. Require administration of any prohibited concomitant medication specified in this protocol during participation in the study
  12. QTc interval > 480 msec

  13. Any of the following abnormalities or abnormal findings from laboratory tests:

    • AST or ALT > 3 times the upper limit of normal
    • Serum creatinine > 1.5 times the upper limit of normal
    • ANC < 1,500/μL, Hemoglobin < 10 g/dL, Platelet count < 100,000/μL
  14. Hepatitis B or C infection or positive test for HIV at screening
  15. History of malignant tumors within the last 5 years prior
  16. Received or used any other IP or investigational device within 4 weeks prior to IP administration
  17. Pregnant or breast-feeding women, or women of childbearing potential and men who do not agree to abstinence or use of effective methods of contraception from the time of obtaining informed consent and during the study
  18. Patients who are deemed ineligible to participate in the study for other reasons by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
CT303
Genetic: CT303

  1. Cohort 1 : Single-dose administration, intravenous injection

    • Dose 1(Starting dose) : 1.0*10^6 cells/kg
    • Dose 2 : 2.0*10^6 cells/kg
    • Dose 3 : 3.0*10^6 cells/kg

  2. Cohort 2 : Multiple-dose administration, intravenous injections (Week 0, Week 4)

    • Dose 1(Starting dose) : 1.0*10^6 cells/kg
    • Dose 2 : 2.0*10^6 cells/kg
    • Dose 3 : 3.0*10^6 cells/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TEAE (treatment-emergent adverse event) incidence rate
Time Frame: Day 0 to Day 28
Evaluate safety through the incidence rate of TEAE (treatment-emergent adverse event) after CT303 administration
Day 0 to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GC Cell Corporation

Investigators

  • Principal Investigator: Seongjin Jo, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Anticipated)

August 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

February 14, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT303A101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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