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

ITBMed

Status and phase: Terminated; Phase 2

Conditions: Kidney Transplantation

Treatments: Biological: TCD601

Study type: Interventional

Funder types: Industry

Identifiers

NCT04803006

TCD601A201

Details and patient eligibility

About

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

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

Arm 1

Experimental group

Description:

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Treatment:

Biological: TCD601

Arm 2

Experimental group

Description:

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Treatment:

Biological: TCD601