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

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medeor Therapeutics, Inc.
• Treatments: Antilymphocyte Serum; Immunosuppressive Agents; Mycophenolic Acid; Tacrolimus

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:

• 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