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

Moderate to Severe Plaque Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05258331
• Other study ID #: CT303A101
• Status: Recruiting
• Phase: Phase 1
• Start date: October 25, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2022
• Source: GC Cell Corporation
• Contact: Soyeon Bae
• Phone: +82-31-280-9972
• Email: sybae[@]gccorp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moderate to Severe Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	CHA Medical School Bundang CHA Medical Center	Gyeonggi-do
Korea, Republic of	Pusan national university hospital	Pusan
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GC Cell Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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