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

NCT05258331 | Unknown Phase 1

• 1 other identifier: CT303A101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Moderate to Severe Plaque Psoriasis

Keywords

Psoriasis

Outcome Measures

Primary Outcomes (1)

• TEAE (treatment-emergent adverse event) incidence rate

  Evaluate safety through the incidence rate of TEAE (treatment-emergent adverse event) after CT303 administration

  Day 0 to Day 28

Study Arms (1)

Single Arm

EXPERIMENTAL

CT303

Genetic: CT303

Interventions

CT303 GENETIC

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

Single Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 19 years old
• 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
• Have moderate to severe plaque psoriasis as defined by PASI score ≥ 12, BSA ≥ 10% and sPGA score ≥ 3
• Patients who have voluntarily decided to participate in the study and signed the informed consent form

You may not qualify if:

• Guttate psoriasis, erythrodermic psoriasis, palmoplantar psoriasis, drug-induced psoriasis, and inverse psoriasis
• History of treatment with cell therapy products including but not limited to mesenchymal stem cells
• Have hypersensitivity, or medical history of clinically significant hypersensitivity, to the IP or its excipients
• Current or history of cardiovascular diseases
• 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
• Use of anticoagulants within 7 days prior to IP administration
• 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
• Severe infection or other uncontrolled active infectious diseases requiring administration of systemic antibiotics, antivirals, etc. within 4 weeks prior to IP administration
• Systemic or local inflammatory diseases requiring systemic anti-inflammatory treatment within 4 weeks prior to IP administration
• 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)
• Require administration of any prohibited concomitant medication specified in this protocol during participation in the study
• QTc interval \> 480 msec

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (3)

CHA Medical School Bundang CHA Medical Center

Gyeonggi-do, 13496, South Korea

RECRUITING

Pusan national university hospital

Pusan, 49241, South Korea

RECRUITING

Seoul national university hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Seongjin Jo

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soyeon Bae

CONTACT

+82-31-280-9972; sybae@gccorp.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 28, 2022
• Study Start: October 25, 2021
• Primary Completion: August 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)