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

• Sponsor: ITB-Med LLC (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04803006
• Collaborator: (none)
• Enrollment: 18
• Locations: 4
• Arms: 3
• Anticipated Duration (Months): 60
• Patients Per Site: 4.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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 de novo living donor renal transplantation.

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Aug 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
Experimental: Arm 2 TCD601administered with non-myeloablative conditioning and standard of care immunosuppression	Biological: TCD601; Investigational Product
Experimental: Arm 3 TCD601administered with non-myeloablative conditioning and standard of care immunosuppression	Biological: TCD601; Investigational Product

Outcome Measures

Primary Outcome Measures

1. The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome [24 months]

   The proportion of patients off immunossupression with good safety and tolerability

Secondary Outcome Measures

1. The incidence of biopsy proven acute rejection, death and graft loss [24 months]

2. The incidence of de novo donor-specific antibody [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 Maryland	Baltimore	Maryland	United States	21201
2	Saint Barnabas Medical Center	Livingston	New Jersey	United States	07039
3	NYU Langone	New York	New York	United States	10016
4	Columbia University Irving Medical Center	New York	New York	United States	10032

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: NCT04803006
• Other Study ID Numbers: TCD601A201
• 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: No

Study Results

No Results Posted as of Jun 16, 2022