Status:
ACTIVE_NOT_RECRUITING
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)
Lead Sponsor:
ITB-Med LLC
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients
Eligibility Criteria
Inclusion
- Key
- Able to understand the study requirements and provide written informed consent before any study assessment is performed
- Male or female patients ≥ 18 to 65 years of age
- Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor
- Key
Exclusion
- Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
- A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
- Recipient with anti-HLA donor-specific antibody (DSA)
Key Trial Info
Start Date :
December 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04803058
Start Date
December 14 2022
End Date
March 1 2030
Last Update
July 8 2025
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
3
Samsung Medical University
Seoul, South Korea