Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants
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|ClinicalTrials.gov Identifier: NCT03606746|
Recruitment Status : Not yet recruiting
First Posted : July 31, 2018
Last Update Posted : August 24, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant Rejection||Biological: MDR-103||Phase 2|
Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the past recipients' immune system to accept the transplanted kidney without the concurrent need for long term use of immunosuppressive drugs.
The purpose of the current Phase 2 study is to demonstrate the efficacy and safety of MDR-103 for the induction of transplant immune tolerance in a prospective, multicenter clinical trial. MDR-103 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Prospective, Multi-center, Open-label Trial to Assess the Safety & Efficacy of Cellular Immunotherapy With MDR-103 for Induction of Mixed Chimerism & Immune Tolerance in Past Recipients of HLA Zero-mismatch, LD Kidney Transplants|
|Estimated Study Start Date :||September 2023|
|Estimated Primary Completion Date :||August 2025|
|Estimated Study Completion Date :||October 2025|
Experimental: Investigational Arm
A low-dose Total Lymphoid Irradiation (TLI) and anti-thymocyte globulin (ATG) combined with a single IV infusion of MDR-103 and standard anti-rejection medications in past recipients of HLA Zero-mismatch living donor kidney transplants.
MDR-103 Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
- Persistent Mixed Chimerism [ Time Frame: At 6 months post initiation of anti-thymocyte globulin (ATG) conditioning therapy ]
The primary efficacy endpoint is the proportion of subjects achieving persistent mixed chimerism in MDR-103 treated recipients of past HLA zero-mismatch living donor kidney transplants.
Persistent Mixed Chimerism - is defined as at least 6 months of persistent WBC mixed chimerism consisting of at least 5% donor cells in whole blood or in at least one WBC lineage (CD3+ T cells, CD33+ myeloid cells, CD19+ B cells, and/or CD56+ NK cells).
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Recipient Inclusion Criteria:
- Past recipient of a first kidney allograft from an HLA-matched, living related donor
- Age ≥18 and ≤70 years
- Single solid organ recipient (kidney only)
- ABO compatibility with donor
Donor Inclusion Criteria:
- HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling, half sibling) relative of the prospective recipient participant
- Age ≥18 and ≤70 years
- Past living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells
Recipient Exclusion Criteria:
- Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
- Baseline positive donor-specific anti-HLA antibody testing
- Is taking immunosuppressive therapy
- Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)
Donor Exclusion Criteria:
- History of autoimmune disorders
- History of type 1 or type 2 diabetes mellitus
- Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV
- History of infection with Zika virus
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606746
|Contact: Lenuta Micsa, MDemail@example.com|
|Responsible Party:||Medeor Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||July 31, 2018 Key Record Dates|
|Last Update Posted:||August 24, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Hematopoietic Stem Cells (HSC)