A Clinical Study to Evaluate CUD005 Injection in Patients with Liver Cirrhosis

NCT06671275 | Enrolling By Invitation Phase 1

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

Brief Summary

A single-arm, open-label, dose-escalation phase I clinical trial to evaluate the safety, tolerability, and preliminary efficacy of CUD005 injection in patients with liver cirrhosis

Conditions

Cirrhosis Liver

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity (DLT) Maximum Tolerated Dose (MTD)

  28 days

Study Arms (1)

Single arm cell therapy

EXPERIMENTAL

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.

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 cell therapy

Eligibility Criteria

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

You may qualify if:

• Subjects voluntarily participated in the study and signed an informed consent form.
• Patients with cirrhosis confirmed by histopathology, endoscopy or imaging examination without determining the etiology and in the decompensated stage.
• Patients with cirrhosis that persists or progresses after adequate etiological treatment;
• Model for End-Stage Liver Disease (MELD) score of 10-16 (including cut-off values).
• Child-Pugh grade of liver cirrhosis is grade B (7\~9 points, including the cut-off value);
• Subjects with unobstructed vascular access , and who can performed peripheral blood mononuclear cell collections.
• 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；
• At the same time, subjects who also had other uncured malignant tumors, except for local skin cancer and cervical cancer in situ that have been adequately treated and have not recurred within 5 years；
• Subjects with a history of prior organ transplantation or tissue regeneration therapy；
• Previously diagnosed hepatocellular carcinoma or uncertain cases (except subjects with abnormal hyperplasia or indeterminate nodules)；
• Subjects with any active, known or suspected autoimmune diseases (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple sclerosis, vasculitis, glomerulonephritis, uveitis, pituitary inflammation, hyperthyroidism, etc.)；
• Subjects who were systematically treated with corticosteroids (\> 10 mg/day of prednisone or other equivalent hormones) or other immunosuppressants within 4 weeks prior to apheresis. In the absence of active autoimmune disease, inhaled or topical corticosteroids therapy and adrenal hormone replacement at doses ≤ 10 mg/day of prednisone efficacy are permitted；
• Patients with grade 2 or above hepatic encephalopathy within 3 months prior to apheresis or current diagnosis (according to the HE grading criteria revised in the 2018 guidelines for the diagnosis and treatment of hepatic encephalopathy in liver cirrhosis);
• Virology shows anti-HCV antibodies, HIV-positive, or syphilis antibodies during the screening period；
• During the screening period, hepatitis B surface antigen positive (except when HBV-DNA quantification \< 20 IU/mL).
• \. Ascites or pleural effusion that cannot be controlled by appropriate intervention, those who require frequent puncture drainage (once a month or more frequently) or those who have received thoracic or ascites drainage within 2 weeks before treatment, except for a small amount of ascites or pleural effusion on imaging；
• Previous or current idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis (imaging only, no hormonal therapy may be enrolled), drug-induced pneumonia, or active pneumonia on screening imaging）；
• Clinical symptoms or diseases of the heart that were not well controlled, eg: (1) NYHA grade 2 or higher cardiac insufficiency, (2) unstable angina, (3) acute myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention；
• \. Subjects with hypertension who were not well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg)；
• \. The screening period check meets the following criteria：
• PLT \<50 ×10\*9/L；

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Lianxin Liu

Hefei, Anhui, 230000, China

Location

MeSH Terms

Conditions

Fibrosis

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Lianxin LX Liu, professor

  The First Affiliated Hospital of University of Science and Technology of China

  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: August 25, 2024
• First Posted: November 4, 2024
• Study Start: June 21, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)