Cellular Immunotherapy in Recipients of Human Leukocyte Antigen (HLA)-Mismatched, Living Donor Kidney Transplants
About the study
The Phase 2 primary objective is to evaluate achievement of persistent mixed chimerism and withdrawal of at least one immunosuppression drug for a minimum of 6 months with no episodes of biopsy-proven acute rejection or transplant kidney loss induced by cellular immunotherapy with MDR-102 in recipients of 1, 2, or 3 out of 6 human leukocyte antigen (HLA)-mismatched, living donor kidney transplants.
The Phase 3 primary objective is to evaluate achievement of induction of immune quiescence by cellular immunotherapy with MDR-102 in recipients of 1, 2, or 3 out of 6 HLA-mismatched, living donor kidney transplants. Immune quiescence is defined as remaining on maintenance immunosuppression monotherapy with Tac or CsA for 12 months or more after completion of anti-rejection immunosuppression drug therapy reduction with no episodes of biopsy-proven acute rejection, transplant kidney loss, or subject deat.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
Recipient Inclusion Criteria:
- Planned recipient of a first kidney allograft from an human leukocyte antigen (HLA)-matched, living related donor. Zero-mismatch transplants are excluded
- Age ≥18 and ≤65 years
- Single solid organ recipient (kidney only)
- ABO compatibility with donor
Donor Inclusion Criteria:
- Human leukocyte antigen (HLA)-mismatched first degree (parent, child or sibling) or second-degree (child of a sibling) relative of the prospective recipient participant. Zero-mismatch transplants are excluded
- Age ≥18 and ≤65 years
- Prepared to be a living related kidney donor, and capable of undergoing granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis of hematopoietic cells
EXCLUSION CRITERIA
Exclusion Criteria:
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
- Prior hematopoietic cell transplant, organ transplant, any cell therapy, or any gene 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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Kidney Transplant Rejection
Age (in years)
18 - 65
Phase
Phase 2/Phase 3
Participants needed
172
Est. Completion Date
Oct 31, 2026
Treatment type
Interventional
Sponsor
Medeor Therapeutics, Inc.
ClinicalTrials.gov identifier
NCT03605654
Study number
MDR-102-mMLK
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