darTregs / National Institute of Allergy and Infectious Diseases - LARVOL DELTA

Cellular Therapies in Transplantation - Regulatory T Cell Therapies and Virus Specific Therapies. (PubMed, Curr Transplant Rep) - "Treg-based therapies, including polyclonal Tregs, donor antigen-reactive Tregs (darTregs), and chimeric antigen receptor Tregs (CAR-Tregs) are being studied to minimize conventional, systemic immunosuppression while preventing graft rejection...By reducing dependence on conventional immunosuppression, cellular therapies provide a promising approach in transplantation. To establish their role in clinical transplantation, further research is needed to optimize dosing and manufacture, improve antigen specificity, and address long-term safety concerns."

Journal • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Immunology • Infectious Disease • Solid Organ Transplantation • Transplant Rejection • Transplantation

Donor Antigen-Reactive Tregs for Tolerance Induction in Liver Transplantation: Early Results of LITTMUS (ITN073ST), a Prospective Clinical Trial (ATC 2024) - P1/2 | "darTreg-CSB is manufactured by coculture of recipient PBMC with irradiated donor splenocytes in the presence of belatacept (Bristol Myers Squibb, NJ) for costimulatory blockade (CSB)...Within 30 months post-LTx, they need to meet eligibility criteria related to each of the following steps: (1) tacrolimus (TAC) minimization and addition of everolimus (EVR) (2) leukapheresis and Treg manufacture (3) lymphodepletion with cyclophosphamide (4) single infusion of darTreg-CSB (5) immunosuppression withdrawal (ISW)... Delayed cellular therapy based on darTreg-CSB was feasible, safe and well-tolerated in LTx recipients but failed to induce tolerance in the majority. Additional interventions or an alternative clinical design may be needed to boost success."

Clinical • Hepatology • Transplantation

ARTEMIS: Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction (clinicaltrials.gov) - P1/2; N=14; Completed; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Active, not recruiting ➔ Completed

Clinical • Trial completion

ARTEMIS: Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction (clinicaltrials.gov) - P1/2; N=13; Active, not recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Recruiting ➔ Active, not recruiting; Trial primary completion date: Aug 2019 ➔ Dec 2019

Clinical • Enrollment closed • Trial primary completion date

deLTa: Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation (clinicaltrials.gov) - P1; N=15; Terminated; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Active, not recruiting ➔ Terminated; Difficulties in manufacturing the cell products essential to the study.

Trial termination

deLTa: Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation (clinicaltrials.gov) - P1; N=15; Active, not recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Recruiting ➔ Active, not recruiting; N=24 ➔ 15; Trial completion date: Jan 2022 ➔ Jun 2019; Trial primary completion date: Jan 2022 ➔ Jun 2019

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date

ARTEMIS: Donor Alloantigen Reactive Tregs (darTregs) for Calcineurin Inhibitor (CNI) Reduction (clinicaltrials.gov) - P1/2; N=18; Recruiting; Sponsor: National Institute of Allergy and Infectious Diseases (NIAID); Trial completion date: Jun 2019 ➔ Apr 2020; Trial primary completion date: Oct 2018 ➔ Aug 2019

Clinical • Trial completion date • Trial primary completion date