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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05258331
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GC Cell Corporation
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Seongjin Jo
Principal Investigator Affiliation Seoul National University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate to Severe Plaque Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Single Arm

CT303

Interventions

Genetic: - CT303

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

Contact a Trial Team

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International Sites

Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

CHA Medical School Bundang CHA Medical Center

Gyeonggi-do, , 13496

Site Contact

Donghyun Kim

terios92@hanmail.net

+82-31-280-9972

Pusan national university hospital, Pusan, Korea, Republic of

Status

Recruiting

Address

Pusan national university hospital

Pusan, , 49241

Site Contact

Byungsoo Kim

dockbs@pusan.ac.kr

+82-31-280-9972

Seoul national university hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul national university hospital

Seoul, , 03080

Site Contact

Seongjin Jo

sj.jo@snu.ac.kr

+82-31-280-9972

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