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

Sponsor

ITB-Med LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04803058

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

2.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Biological: TCD601	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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 de Novo Living Donor Renal Transplantation

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Arm 1

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Biological: TCD601

Investigational Product

Outcome Measures

Primary Outcome Measures

The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance [24 months]
The proportion of patients off immunossupression with good safety and tolerability

Secondary Outcome Measures

Incidence of biopsy proven acute rejection, death, and graft loss [24 months]
The incidence of de novo DSA [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 or second 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago	Chicago	Illinois	United States	60637
2	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
3	Mayo Clinic	Rochester	Minnesota	United States	55905
4	Weill Cornell	New York	New York	United States	10065
5	UT Southwestern Medical Center	Dallas	Texas	United States	75390

Sponsors and Collaborators

ITB-Med LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ITB-Med LLC

ClinicalTrials.gov Identifier:

NCT04803058

Other Study ID Numbers:

TCD601A202

First Posted:

Mar 17, 2021

Last Update Posted:

Jun 16, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 16, 2022