Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients

Launched by QUELL THERAPEUTICS LIMITED · Feb 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called QEL-001, which aims to help people who have received a liver transplant. Specifically, the trial is looking at how safe and effective QEL-001 is in preventing the body from rejecting the transplanted liver after stopping the usual medications that suppress the immune system. QEL-001 is made from the patient’s own cells, which are modified to support the acceptance of the donated liver.

To participate in this trial, you must be between 18 and 75 years old and have received a liver transplant that did not perfectly match your body’s tissue type (HLA A2-mismatch) at least 12 months ago but no more than 5 years ago. You should also be stable on your current immunosuppressive medications for at least 12 weeks. Participants will receive QEL-001 and will be closely monitored for their safety and any changes in their health. It’s important to know that there are certain medical conditions and past health issues that could make you ineligible, so a thorough assessment will be done. This trial is currently recruiting participants, and your involvement could contribute to finding better ways to support liver transplant patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent.
• • Subject who are HLA A2/A28 negative who have received HLA A2-mismatch liver transplant 12 months to 5 years prior to study entry.
• • Able and willing to use contraception.
• • Be on stable maintenance of immunosuppression for at least 12 weeks prior to study entry.
• Exclusion Criteria:
• • Severe cardiac, respiratory disease or any other major organ dysfunction.
• • Subjects with prior non-liver solid organ or hematopoietic stem cell transplant.
• • Known hypersensitivity to study medication ingredients, protocol defined immunosuppressive medications, or a significant allergic reaction to any drug.
• • Positive serology for human immunodeficiency virus (HIV), active or latent tuberculosis (TB) or other clinically active local or systemic infection.
• • Use of investigational agents within 3 months of screening.
• • Subjects with history of autoimmune disease requiring use of immunosuppression or biologics within 24 months prior to study entry.
• • Subject with history of malignancy in the past 5 years.
• • Medical or social condition that is not compatible with adequate study follow-up and any other reason that, in the opinion of the Site Investigator or Medical Monitor, would render the subject unsuitable for participation in the study.
• * Protocol defined laboratory value for the following parameters:
• • Alanine aminotransferase (ALT) and either alkaline phosphatase (ALP) or gamma-glutamyl transferase (GGT),
• • Kidney function e.g. eGFR,
• • White blood cells,
• • Hemoglobin,
• • Platelets.