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

Kidney Transplantation Clinical Trial

Official title:

An Adaptive, Regimen Finding, Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-myeloablative Conditioning, for Tolerance Induction in de Novo Living Donor Renal Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04803006
• Other study ID #: TCD601A201
• Status: Recruiting
• Phase: Phase 2
• Start date: January 17, 2023
• Est. completion date: January 2030

Study information

• Verified date: March 2024
• Source: ITB-Med LLC
• Contact: Shannon Zentmeyer, BSN
• Phone: 347-326-1985
• Email: shannon.zentmeyer[@]itb-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 de novo living donor renal transplantation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: January 2030
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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 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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Biological:
• TCD601
Investigational Product

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Cooperman Barnabas Medical Center	Livingston	New Jersey
United States	Columbia University Irving Medical Center	New York	New York
United States	NYU Langone	New York	New York
United States	UCSF Connie Frank Transplant Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
ITB-Med LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The incidence of biopsy proven acute rejection, death and graft loss		24 months
Secondary	The incidence of de novo donor-specific antibody		24 months