Clinical trial

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 de Novo Living Donor Renal Transplantation

Name

TCD601A202

Description

The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in de novo living donor renal transplant recipients

Trial arms

Trial start

2022-12-14

Estimated PCD

2024-12-01

Trial end

2027-12-01

Status

Recruiting

Phase

Early phase I

Treatment

TCD601

Investigational Product

Arms:

Arm 1

Size

Primary endpoint

The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance

24 months

Eligibility criteria

Key Inclusion Criteria: * Able to understand the study requirements and provide written informed consent before and study assessment is performed. * Male or female patients ≥ 18 to 60 years of age. * Recipient of a first renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor. Key Exclusion Criteria: * Women of child-bearing potential * Subjects with a history of cancer * Donor-specific antibody

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

Updated at

2024-03-29

1 organization

1 product

1 indication

Organization

ITB-Med

Product

TCD601

Indication

Kidney Transplant