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Cirrhosis LiverPhase 1NCT06671275

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

A Phase 1 study testing Cell therapy in people with Cirrhosis Liver, run by Anhui Provincial Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cirrhosis Liver
What is being tested?
Cell therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
21 Jun 2024to Jul 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.Subjects voluntarily participated in the study and signed an informed consent form.
  • 2.Patients with cirrhosis confirmed by histopathology, endoscopy or imaging examination without determining the etiology and in the decompensated stage.
  • 3.Patients with cirrhosis that persists or progresses after adequate etiological treatment;
  • 4.Model for End-Stage Liver Disease (MELD) score of 10-16 (including cut-off values).
  • 5.Child-Pugh grade of liver cirrhosis is grade B (7~9 points, including the cut-off value);
  • 6.Subjects with unobstructed vascular access , and who can performed peripheral blood mononuclear cell collections.
  • 7.Subjects were able to communicate well with the investigator, cooperate with follow-up work, and understand and comply with the requirements of the study.

Who cannot join

  • 1. Subjects who were Allergic to cell therapy, steroids, and related drugs used in the study；
  • 2.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；
  • 3.Subjects with a history of prior organ transplantation or tissue regeneration therapy；
  • 4.Previously diagnosed hepatocellular carcinoma or uncertain cases (except subjects with abnormal hyperplasia or indeterminate nodules)；
  • 5.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.)；
  • 6.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；
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  • 7.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);
  • 8.Virology shows anti-HCV antibodies, HIV-positive, or syphilis antibodies during the screening period；
  • 9.During the screening period, hepatitis B surface antigen positive (except when HBV-DNA quantification < 20 IU/mL).
  • 10. 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；
  • 11.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）；
  • 12.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；
  • 13. Subjects with hypertension who were not well controlled by antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg)；
  • 14. The screening period check meets the following criteria：
  • PLT <50 ×10*9/L；
  • Alpha-fetoprotein was more than twice the upper limit of normal, or ALT> 5 times the upper limit of normal；
  • Serum albumin < 30 g/L and other causes such as malnutrition or kidney disease are excluded；
  • INR > 1.5 or PT extension more than normal +5 seconds or more。
  • 15.Any of the following bleeding occurs：
  • Previous portal hypertension bleeding；
  • There were episodes of active bleeding that required hospitalization within 1 month prior to apheresis；
  • History of gastrointestinal bleeding or definite gastrointestinal bleeding or bleeding events due to oesophageal and/or gastric varices within 1 month prior to apheresis；
  • Known hereditary or acquired bleeding and thrombophilia (eg, hemophilia, coagulopathy, etc)。
  • 16.Arteriovenous thrombotic events such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism occurred within 1 month before apheresis。
  • 17.Anticoagulants or antiplatelet drugs were used 3 days before treatment；
  • 18.Subjects had active infection within 2 weeks before apheresis, or fever of unknown origin ≥ 38.5°C within 7 days before treatment, or WBC count ≥15×109/L before apheresis, or continued antibiotics；
  • 19. Pregnant and lactating women who were currently breastfeeding or are not currently breastfeeding but less than 6 months after delivery；
  • 20.Female subjects (or male subjects) of childbearing age who intend to have a desire to have children during the study period (from the signing of the informed consent form) to 30 days after the end of administration and refuse to use effective contraception；
  • 21.Have participated in other drug or device clinical studies within 4 weeks prior to screening；
  • 22. Regular drinkers in the 1 month (30 days) prior to screening, i.e. those who drank more than 14 units of alcohol per week (1 unit = 360 beer or 45 mL of spirits or 150 mL of wine with 40% alcohol)；
  • 23. 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；
  • 24. Other factors that the investigator deemed unsuitable for inclusion or that influenced participants' participation in or completion of the study。

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Lianxin Liu

    Hefei, Anhui, 230000

Other trials in China

About this study

Official title: 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

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

Read the 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.

Conditions
Cirrhosis Liver
Being tested
Cell therapy
Keywords
macrophage, Cirrhosis, cell therapy, PBMC, safety, tolerability, MTD, DLT, dose escalation
Medical subject headings
Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cell therapyBiological

    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

Study groups in NCT06671275
Study groupRoleWhat they receive
Single arm cell therapyExperimentalThe 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.
Receives: Biological: Cell therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose Limiting Toxicity (DLT) Maximum Tolerated Dose (MTD)

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2024
  2. Study start21 Jun 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06671275
Sponsor's protocol ID
KDS-CUD
Status last verified
Nov 2024
First submitted
25 Aug 2024
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cell therapy in people with Cirrhosis Liver, run by Anhui Provincial Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) Maximum Tolerated Dose (MTD) (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06671275.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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