NCT04803058TerminatedPhase 2
A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-Myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, for Tolerance Induction in Living Donor Renal Transplantation
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- ITB-Med LLC
- Enrollment
- 7
- Locations
- 6
- Primary Endpoint
- The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance
Study Overview
Brief Summary
The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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)
Arms & Interventions
Arm 1
Experimental
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Intervention: TCD601 (Biological)
Outcomes
Primary Outcomes
The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance
Time Frame: 24 months
The proportion of patients off immunosuppression with good safety and tolerability
Secondary Outcomes
- The incidence of DSA(24 months)
- Incidence of biopsy proven acute rejection, death, and graft loss(24 months)
Investigators
Study Sites (6)
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