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- LARVOL DELTA
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April 15, 2025
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
(clinicaltrials.gov)
- P2 | N=126 | Recruiting | Sponsor: TolerogenixX GmbH | Trial completion date: Jun 2027 ➔ Dec 2028 | Trial primary completion date: Jun 2025 ➔ Dec 2026
Trial completion date • Trial primary completion date • Transplantation
December 04, 2023
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
(clinicaltrials.gov)
- P2 | N=126 | Recruiting | Sponsor: TolerogenixX GmbH | Trial completion date: May 2026 ➔ Jun 2027 | Trial primary completion date: May 2024 ➔ Jun 2025
Immune cell • Trial completion date • Trial primary completion date • Transplantation
July 24, 2023
Five-year follow-up of a phase I trial of donor-derived modified immune cell infusion in kidney transplantation.
(PubMed, Front Immunol)
- P1 | "The administration of modified immune cells (MIC) before kidney transplantation led to specific immunosuppression against the allogeneic donor and a significant increase in regulatory B lymphocytes...https://clinicaltrials.gov/, identifier NCT02560220 (for the TOL-1 Study). EudraCT Number: 2014-002086-30."
Immune cell • Journal • P1 data • Retrospective data • Infectious Disease • Transplant Rejection • Transplantation • CD27
April 12, 2023
Modified Immune Cell (MIC) Therapy disrupts Tertiary Lymphoid Structures in Murine Lupus Nephritis (P762)
(IMMUNOLOGY 2023)
- "Induction of tolerance can be achieved with Modified Immune Cells (MIC) by infusion of mononuclear cells challenged with mitomycin C (MMC). However, regulatory T-cells remained unchanged indicative of a B-cell centric treatment mechanism. Our data provides a putative in vivo mechanism how MIC treatment inhibits progression of active lupus nephritis by the destruction of tertiary lymphoid structures within the kidney."
Immune cell • Preclinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Solid Organ Transplantation • Transplantation
November 15, 2022
Individualised immunosuppression with intravenously administered donor-derived modified immune cells compared with standard of care in living donor kidney transplantation (TOL-2 Study): protocol for a multicentre, open-label, phase II, randomised controlled trial.
(PubMed, BMJ Open)
- P2 | "Donor-derived modified immune cells (MIC) induced long-term specific immunosuppression against the allogeneic donor in preclinical models of transplantation...The results from the TOL-2 Study will be published in peer-reviewed medical journals and will be presented at symposia and scientific meetings. NCT05365672."
Clinical protocol • Journal • P2 data • Immunology • Infectious Disease • Nephrology • Transplant Rejection • Transplantation
October 13, 2022
Modified Immune Cell (MIC) Therapy Disrupts Tertiary Lymphoid Structures in Murine Lupus Nephritis
(KIDNEY WEEK 2022)
- "Funding Commercial Support Background Induction of tolerance can be achieved with Modified Immune Cells (MIC) by infusion of mononuclear cells challenged with mitomycin C (MMC). However, regulatory T-cells remained unchanged indicative of a B-cell centric treatment mechanism. Conclusion Our data provides a putative in vivo mechanism how MIC treatment inhibits progression of active lupus nephritis by the destruction of tertiary lymphoid structures within the kidney."
Preclinical • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Solid Organ Transplantation • Transplantation
September 25, 2022
Induction of Long-lasting Regulatory B Lymphocytes by Modified Immune Cells in Kidney Transplant Recipients.
(PubMed, J Am Soc Nephrol)
- "Conclusions These results indicate that donor-specific immunosuppression after MIC infusion is long-lasting and associated with a striking increase in regulatory B lymphocytes. Donor-derived MICs appear to be an immunoregulatory cell population which, when administered to recipients prior to transplantation, may exert a beneficial effect on kidney transplants."
Journal • Transplant Rejection • Transplantation
May 09, 2022
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
(clinicaltrials.gov)
- P2 | N=126 | Not yet recruiting | Sponsor: TolerogenixX GmbH
New P2 trial • Transplantation
May 10, 2022
Clinical Trial With Donor Modified Immune Cells in Living Donor Kidney Transplantation
(clinicaltrials.gov)
- P2 | N=126 | Recruiting | Sponsor: TolerogenixX GmbH | Not yet recruiting ➔ Recruiting
Enrollment open • Transplantation
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