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

MDR-103-L2K

The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.

2024-12-01

2025-08-01

2025-10-01

Not yet recruiting

Early phase I

25

Inclusion Criteria: 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 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 * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ESTIMATED'}}

2023-10-19