For Healthcare Professionals

Cellular Immunotherapy in Recipients of Human Leukocyte Antigen (HLA)-Mismatched, Living Donor Kidney Transplants

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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.
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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:


  1. Planned recipient of a first kidney allograft from an human leukocyte antigen (HLA)-matched, living related donor. Zero-mismatch transplants are excluded
  2. Age ≥18 and ≤65 years
  3. Single solid organ recipient (kidney only)
  4. ABO compatibility with donor

Donor Inclusion Criteria:


  1. 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
  2. Age ≥18 and ≤65 years
  3. 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:


  1. Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
  2. Baseline positive donor-specific anti-HLA antibody testing
  3. Is taking immunosuppressive therapy
  4. Prior hematopoietic cell transplant, organ transplant, any cell therapy, or any gene therapy
  5. Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)

Donor Exclusion Criteria:


  1. History of autoimmune disorders
  2. History of type 1 or type 2 diabetes mellitus
  3. Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV
  4. History of infection with Zika virus

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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