Status:
ACTIVE_NOT_RECRUITING
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PANORAMA)
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 determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolera...
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 first renal transplant from a non-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 :
January 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2030
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04803006
Start Date
January 17 2023
End Date
July 1 2030
Last Update
July 10 2025
Active Locations (2)
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1
UCSF Connie Frank Transplant Center
San Francisco, California, United States, 94143
2
Columbia University Irving Medical Center
New York, New York, United States, 10032