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Clinical Trials

Date: 2022-03-28

Type of information: Clinical trial authorisation

phase: 2b

Announcement: clinical trial authorization

Company: TolerogenixX (Germany)

Product: MIC-Lx cell treatment

Action mechanism: cell therapy. MIC-Lx is a cell therapy prepared from an organ donor’s peripheral blood mononuclear cells (PBMC) obtained by leukapheresis. Cells are modified using TolerogenixX´ proprietary MIC technology and, subsequently, MIC-Lx is intravenously administered to the organ recipient prior to transplantation.

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Trial details: TOL-2 is designed as an open, randomized-controlled, multi-center Phase IIb study of individualized immunosuppression with intravenously administered, donor modified immune cells (MIC-Lx) and will be conducted in patients undergoing living donor kidney transplantation, comparing treatment to standard-of-care (SoC).

Latest news:

  • On March 28, 2022,  TolerogenixX, a biopharmaceutical company developing personalized cellular therapies aimed at achieving sustained immune tolerance to combat organ rejection and autoimmune diseases, announced that the German regulatory authority Paul-Ehrlich-Institut has approved a Phase IIb clinical trial for its MIC-Lx cell therapy designed to induce immune tolerance. The trial codenamed TOL-2 is scheduled to start in Q2, 2022. , comparing treatment to standard-of-care (SoC). The TOL-2 trial is planned to enroll 63 transplant couples, consisting of a donor and a transplant recipient. The 63 organ recipients will be randomized 2:1 to treatment with MIC-Lx (MIC group, N=42) or immunosuppression according to standard-of-care (control arm, N=21). Follow up will be conducted 367 (±28) days after MIC application, corresponding to 360 days after transplantation of the living kidney. In addition, a long-term follow-up will be performed for 2 years after the 12-month follow-up period. Endpoints have been chosen to determine efficacy of MIC treatment in terms of achieving an operational tolerance-like phenotype compared to standard-of-care, among them absence of biopsy-proven acute rejection, graft loss, graft dysfunction, or death on visit day 367 as well as absence of de novo donor-specific human leukocyte antigen (HLA) antibodies. Secondary endpoints comprise, among others, the number of patient-relevant infections during the first year after transplantation. The Company previously completed the TOL-1 Phase Ib study, in which kidney transplant patients successfully achieved immune tolerance and absence of organ rejection, based on three-year follow-up data. These results were very positively received in an editorial alongside the publication in the Journal of Clinical Investigation in 2020. TolerogenixX also has completed multiple preclinical studies demonstrating application of its technology to achieve antigen-specific immune tolerance and disease-modifying effects in a broad range of autoimmune diseases.

Is general: Yes