To Evaluate the Clinical Study of CUD005 Injection in Patients With Cirrhosis

NCT06296095 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: KDS-CUD-1
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Cirrhosis, Liver

Keywords

Cirrhosis; cell therapy; PBMC; safety; tolerability; MTD; DLT; dose escalation

Outcome Measures

Primary Outcomes (1)

• DLT,MTD

  Dose-limiting toxicity（DLT）: frequency of occurrence, level of dose of DLT toxicity;Maximum tolerated dose (MTD)

  28 days

Secondary Outcomes (3)

• fibrosis staging and inflammatory grading

  180 days

• All-cause mortality

  1 year

• TE（Transient elastography）

  1 year

Other Outcomes (1)

• MELD（Model for End-stage Liver Disease）

  1 year

Study Arms (1)

Single arm

EXPERIMENTAL

cell therapy

Biological: Cell therapy

Interventions

Cell therapy BIOLOGICAL

Subjects were placed sequentially into three different dose groups, 5.0×107 cells/time (low-dose group), 1.5×108 cells/time (medium-dose group), and 5.0×108 cells/time (high-dose group) for dose escalation

Single arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Anhui province hospital

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Lianxin LX Liu, Professor

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: March 6, 2024
• Study Start: August 9, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)