Clinical trial

An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in de Novo Living Donor Renal Transplantation

Name

TCD601A201

Description

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 tolerance induction in de novo living donor renal transplantation.

Trial arms

Trial start

2023-01-17

Estimated PCD

2027-01-01

Trial end

2030-01-01

Status

Recruiting

Phase

Early phase I

Treatment

TCD601

Investigational Product

Arms:

Arm 1, Arm 2, Arm 3

Size

Primary endpoint

The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome

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': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}

Updated at

2024-03-29

1 organization

1 product

1 indication

Organization

ITB-Med

Product

TCD601

Indication

Kidney Transplant