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

February 4, 2026 updated by: ITB-Med LLC

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Samsung Medical University
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Biological: TCD601
Investigational Product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of biopsy proven acute rejection, death, and graft loss
Time Frame: 24 months
24 months
The incidence of DSA
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ITB-Med LLC

Investigators

  • Study Director: Tracy Killingsworth, Nefro Avillion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

March 14, 2021

First Submitted That Met QC Criteria

March 14, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TCD601A202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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