A Single-center, Single-arm, Open-label, Dose-escalation Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of CUD005 Injection in Patients With Cirrhosis

Anhui Provincial Hospital1 site in 1 country9 target enrollmentAugust 9, 2023

ConditionsCirrhosis, Liver

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cirrhosis, Liver
Sponsor: Anhui Provincial Hospital
Enrollment: 9
Locations: 1
Primary Endpoint: DLT,MTD
Status: Enrolling By Invitation
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a single-center, single-arm, open-label, dose-escalation clinical study, to evaluate the tolerability, safety and preliminary efficacy of CUD005 injection in patients with cirrhosis

Detailed Description

The study was designed according to the 3+3 principle, with a total of 3 dose levels and dose escalation. Low-dose group: 5.0×107 cells/time; Medium-dose group: 1.5×108 cells/time; High-dose group: 5.0×108 cells/time. Subjects were sequentially placed in 3 different dose groups administered as a single peripheral intravenous dose. According to the enrollment restriction design, a total of a minimum of 9 subjects are expected to be enrolled, and the final sample size depends on the number of DLT, the number of dose groups ascended before DLT is observed, and the MTD is determined.

Registry

clinicaltrials.gov

Start Date

August 9, 2023

End Date

December 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Anhui Provincial Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•BMI≤30 kg/m2
•The results of liver histopathological examination were consistent with the Ishak stage of liver fibrosis ≥3 points；
•Consent to liver histopathological examination before and after cell therapy (The subject is exempted from liver histopathological examination during the screening period, if he has been performed liver histopathological examination within 2 months before signing the informed consent)；
•Subjects were able to communicate well with the investigator, cooperate with follow-up work, and understand and comply with the requirements of the study.

Exclusion Criteria

•Subjects who were Allergic to cell therapy, steroids, and related drugs used in the study；
•Have malignant tumors, history of organ transplantation or tissue regeneration therapy, active, known or suspected autoimmune diseases, idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, active pneumonia, heart disease that is not well controlled, hypertension, etc;
•Subjects with stage III or IV hepatic encephalopathy within 3 months before apheresis or currently diagnosed；
•Virology shows anti-HCV antibodies, HIV-positive, or syphilis antibodies during the screening period；
•Subjects were HBV surface antigen positive and HBV-DNA titer was ≥ 20 IU/mL during the screening period；
•Subjects with clinically symptomatic ascites or pleural effusions requiring puncture drainage. Or who had received thoracic and ascites drainage within 2 weeks prior to treatment, had may only show a small amount of ascites or pleural effusions on imaging, except in those without clinical symptoms；
•According to the judgment of the investigator, the subjects had other factors that may cause the study to be terminated halfway, such as other serious concomitant diseases (such as severe diabetes, mental illness, drug use, etc.), serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.