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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Moderate to Severe Plaque Psoriasis

Intervention / Treatment
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* Genetic: CT303


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 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 Exclusion Criteria: 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 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 Hepatitis B or C infection or positive test for HIV at screening History of malignant tumors within the last 5 years prior Received or used any other IP or investigational device within 4 weeks prior to IP administration 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 Patients who are deemed ineligible to participate in the study for other reasons by the investigator

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>CT303 | Genetic: CT303<br>* 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 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis