NCT04803058

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2022

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 14, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2026

Completed
Last Updated

July 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

March 14, 2021

Last Update Submit

July 10, 2026

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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

    24 months

Secondary Outcomes (2)

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

    24 months

  • The incidence of DSA

    24 months

Study Arms (1)

Arm 1

EXPERIMENTAL

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Biological: TCD601

Interventions

TCD601BIOLOGICAL

Investigational Product

Arm 1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Samsung Medical University

Seoul, South Korea

Location

Study Officials

  • Tracy Killingsworth

    Nefro Avillion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 17, 2021

Study Start

December 14, 2022

Primary Completion

February 17, 2026

Study Completion

February 17, 2026

Last Updated

July 13, 2026

Record last verified: 2026-02

Locations

US(2)KR(1)