QEL-001 / Quell Therap - LARVOL DELTA

CAR-Treg cell therapy to induce tolerance in liver transplantation – LIBERATE clinical trial (ESGCT 2024) - P1/2 | "LIBERATE is a single-arm, open-label, multi-center, first-in-human, phase I/II clinical trial that is investigating the use of autologous anti-HLA-A2 CAR-Tregs (QEL-001) in HLA-A2 negative adult liver transplant patients that received a graft from an HLA-A2 positive donor (NCT05234190)...The products infused to patients in the LIBERATE safety cohort have shown to be safe and well tolerated. CAR-Tregs were able to engraft and persist while maintaining their suppressive phenotype, providing key evidence to support further evaluation of the use of CAR-Tregs to induce operation tolerance in liver transplant patients."

Clinical • IO biomarker • Inflammation • Transplantation • CTLA4 • FOXP3

LIBERATE: A Phase I/II Clinical Trial of QEL-001 CAR-Treg Cell Therapy to Induce Tolerance and Allow Removal of Immune Suppression in Liver Transplantation (ESGCT 2025) - No abstract available

Clinical • P1/2 data • Transplantation

QEL-001 LIBERATE study expansion cohort, CAR (Chimeric Antigen Receptor) T regulatory (Treg) cells engraftment and expansion following rATG (rabbit anti-thymocyte globulin) conditioning in post liver transplantation (EASL 2025) - No abstract available

Preclinical • Hepatology • Transplantation

QEL-001 LIBERATE study expansion cohort, CAR (Chimeric Antigen Receptor) T regulatory (Treg) cells engraftment and expansion following rATG (rabbit anti-thymocyte globulin) conditioning in post liver transplantation (EASL 2025) - P1/2 | "QEL- 001 infusion after rATG conditioning was well tolerated in patients treated to date. Specific T-cell lymphodepletion was apparent one week post ATG which subsequently enhanced QEL- 001 engraftment and durability in circulation compared with previous data in the safety cohort. Additional clinical and mechanistic data will be presented at the Congress."

Preclinical • Hepatology • Pain • Transplantation • CD4 • CD8 • FOXP3

THE SAFETY AND TOLERABILITY OF QEL-001, AN AUTOLOGOUS CHIMERIC ANTIGEN RECEPTOR (CAR) T REGULATORY (TREG) CELL THERAPY, IN LIVER TRANSPLANTATION – A SAFETY COHORT IN THE LIBERATE STUDY (AASLD 2024) - P1/2 | "QEL-001 was well-tolerated in the safety cohort. QEL-001 trafficked and engrafted in the transplanted livers. Current data supports further QEL-001 dosing with progression to the efficacy cohort in LIBERATE."

Clinical • Hepatology • Infectious Disease • Transplantation • CD8 • FOXP3

Phase 1/2 Clinical Trial Using a CAR-Treg Cell Therapy to Induce Tolerance in Liver Transplant Recipients (ATC 2024) - P1/2 | "LIBERATE is a single-arm, open-label, multi-country, first-in-human, phase I/II clinical trial that is using autologous anti-HLA-A2 CAR-Tregs (QEL-001) in adult non-autoimmune HLA-A2 mismatched LT recipients 1-5 years post-transplantation (NCT05234190).* We have developed a GMP manufacturing process that allows the generation of engineered Tregs from liver transplant patients, which express a CAR designed to recognise the HLA-A2 protein present on the transplanted liver, a FOXP3 phenotype lock and an inducible safety swich... Overall, we have demonstrated that Tregs from liver transplant patients can be isolated and expanded to generate engineered CAR-Tregs with improved safety and therapeutic characteristics. The products infused to patients have shown to be safe and well tolerated, providing key evidence to support the use of CAR-Tregs to induce operation tolerance in LT patients and decrease the side-effects of IS."

Clinical • P1/2 data • Cardiovascular • Hepatology • Immunology • Infectious Disease • Oncology • Transplantation • FOXP3

Chimeric Antigen Receptor Engineered Tregs with Donor Specificity and Enhanced Functional Stability for the Induction of Liver Transplantation Tolerance (ASGCT 2024) - "Finally, QEL-001 displays durable immunoregulation of inflammatory responses in a humanized model of xenoGvHD supporting its therapeutic efficacy and product safety. Overall, the QEL-001 multi-modular approach overcomes the limitations of previous Treg-directed therapies and pioneers the clinical implementation of autologous cell therapies for the induction of immune tolerance in liver transplanted patients."

IO biomarker • Graft versus Host Disease • Hepatology • Inflammation • Transplantation • CD69 • CTLA4 • FOXP3 • TNFRSF9

LIBERATE: Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients (clinicaltrials.gov) - P1/2 | N=33 | Recruiting | Sponsor: Quell Therapeutics Limited | Trial completion date: Mar 2039 ➔ Mar 2040 | Trial primary completion date: Jun 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Hepatology • Liver Failure • Transplantation

LIBERATE: Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients (clinicaltrials.gov) - P1/2 | N=33 | Recruiting | Sponsor: Quell Therapeutics Limited | Trial completion date: Jun 2038 ➔ Mar 2039 | Trial primary completion date: Dec 2024 ➔ Jun 2025

Trial completion date • Trial primary completion date • Hepatology • Liver Failure • Transplantation