A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)

Phase 2Active Not RecruitingNCT04803058

ITB-Med LLC18 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplantation

Interventions

TCD601BIOLOGICAL

Investigational Product

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Key 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 Key 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)

Locations (3)

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Samsung Medical University

Seoul, South Korea

Outcomes

Primary Outcomes

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

The proportion of patients off immunosuppression with good safety and tolerability

Time frame: 24 months

Secondary Outcomes

Incidence of biopsy proven acute rejection, death, and graft loss

Time frame: 24 months

The incidence of DSA

Time frame: 24 months

Data from ClinicalTrials.gov

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