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

• Status: Recruiting
• Trial end date: 2038-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and tolerability of QEL-001 in the prevention of allograft rejection following immunosuppression withdrawal in liver transplantation. QEL-001 is a product made from a liver transplant recipient's own immune cells, which are genetically modified and designed to help the transplant recipient's body accept their donated liver and prevent their immune system from rejecting it.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Quell Therapeutics Limited

Criteria

Inclusion Criteria:

• Written informed consent.

• Subject who received HLA A2-mismatch liver transplant 12 months to 5 years prior to study entry.

• Able and willing to use contraception.

Exclusion Criteria:

• 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.

• Subjects with history of autoimmune disease.

• 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.