A Single-arm, Open-label, Multi-center, Phase I/II Study Evaluating the Safety and Clinical Activity of QEL-001, an Autologous CAR T Regulatory Cell Treatment Targeting HLA-A2, in HLA-A2/ A28neg Patients That Have Received an HLA-A2pos Liver Transplant.

Status: Recruiting

Location: See all (10) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1/Phase 2

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body accept their donated liver and prevent their immune system from rejecting it once immune suppression is withdrawn.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 75

Healthy Volunteers: f

View:

• 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.

Locations

Other Locations

Belgium

H. Saint Luc

RECRUITING

Brussels

Hopital Erasme

RECRUITING

Brussels

UZ Leuven

RECRUITING

Leuven

Spain

H. Clinic Barcelona

RECRUITING

Barcelona

Hospital Reina Sofia

RECRUITING

Córdoba

G. Gergorio Maranon

RECRUITING

Madrid

United Kingdom

Queen Elizabeth Hospital

RECRUITING

Birmingham

Cambridge University Hospitals NHS Foundation Trust

RECRUITING

Cambridge

King's College Hospital NHS Foundation Trust

RECRUITING

London

Royal Free London NHS Foundation Trust

RECRUITING

London

Contact Information

Primary

Quell Therapeutics Clinical Trials

contact@quell-tx.com

+44(0)2070969012

Time Frame

Start Date: 2022-01-21

Estimated Completion Date: 2040-03

Participants

Target number of participants: 33

Treatments

Experimental: Treatment group

Related Therapeutic Areas

Liver Transplant

Liver Failure

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A Single-arm, Open-label, Multi-center, Phase I/II Study Evaluating the Safety and Clinical Activity of QEL-001, an Autologous CAR T Regulatory Cell Treatment Targeting HLA-A2, in HLA-A2/ A28neg Patients That Have Received an HLA-A2pos Liver Transplant.

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