NCT04803006

Brief Summary

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 living donor renal transplantation

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2023

Typical duration for phase_2

Geographic Reach
1 country

1 active site

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
1.8 years until next milestone

Study Start

First participant enrolled

January 17, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

March 14, 2021

Last Update Submit

February 4, 2026

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

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

    The proportion of patients off immunosuppression with good safety and tolerability

    24 months

Secondary Outcomes (2)

  • The incidence of biopsy proven acute rejection, death and graft loss

    24 months

  • The incidence of de novo donor-specific antibody

    24 months

Study Arms (2)

Arm 1

EXPERIMENTAL

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Biological: TCD601

Arm 2

EXPERIMENTAL

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Biological: TCD601

Interventions

TCD601BIOLOGICAL

Investigational Product

Arm 1Arm 2

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 first renal transplant from a non-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 (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Study Officials

  • Tracy Killingsworth

    Nefro Avillion

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 17, 2021

Study Start

January 17, 2023

Primary Completion

October 30, 2025

Study Completion

October 30, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

US(1)