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

NCT05234190 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: QEL-001-CLN-012021-001379-18
• Study Type: interventional
• Target: 33
• Locations: 3 countries
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of QEL-001 in the prevention of liver transplant rejection following immunosuppression withdrawal. QEL-001 is a product made from a patients own 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body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.

Conditions

Rejection; Transplant, Liver; Liver Failure; Liver Diseases

Keywords

Regulatory T cells; Chimeric Antigen Receptor; Autologous; Genetically modified cells

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

  Incidence of protocol defined Dose Limiting Toxicities (DLTs).

  28 Days post infusion

• Long-term safety

  Incidence and grade of treatment-emergent adverse events (TEAEs), including serious adverse events (SAEs) according to CTCAE V5.0.

  Day of infusion through to Week 82 and up to 15 years post infusion

Secondary Outcomes (3)

• Immunosuppression related outcome

  2 months and 1 year post withdrawal of immune suppression

• Tolerance related outcome

  1 year following immune suppression withdrawal

• Composite efficacy failure outcome

  1 year following immune suppression withdrawal

Other Outcomes (2)

• Assess Safety Related Events

  Up to 82 weeks post infusion

• Presence of Replication Competent Lentivirus

  up to 52 weeks post infusion

Study Arms (1)

Treatment group

EXPERIMENTAL

Drug: QEL-001

Interventions

QEL-001 DRUG

QEL-001 is an autologous therapy that is composed of engineered regulatory T cells transduced with a lentiviral vector containing a CAR directed against HLA-A2. Treatment will be given via an IV infusion.

Also known as: HLA-A2 CAR-Treg

Treatment group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Quell Therapeutics Limited: lead

Study Sites (10)

H. Saint Luc

Brussels, Belgium

Location

Hopital Erasme

Brussels, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

H. Clinic Barcelona

Barcelona, Spain

Location

Hospital Reina Sofia

Córdoba, Spain

Location

G. Gergorio Maranon

Madrid, Spain

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Rejection, Psychology; Liver Failure; Liver Diseases

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Hepatic Insufficiency; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: January 21, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): September 1, 2040
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); GB (4); BE (3)