A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)
Purpose
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients
Condition
- Kidney Transplantation
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1 |
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression |
|
Recruiting Locations
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Contact:
Research Coordinator
Research Coordinator
More Details
- Status
- Recruiting
- Sponsor
- ITB-Med LLC