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

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 Living Donor Renal Transplantation

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04803006

Enrollment

Registered

2021-03-17

Start date

2023-01-17

Completion date

2025-10-30

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation

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

Interventions

BIOLOGICALTCD601

Investigational Product

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion 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)

Design outcomes

Primary

Measure	Time frame	Description
The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome	24 months	The proportion of patients off immunosuppression with good safety and tolerability

Secondary

Measure	Time frame
The incidence of biopsy proven acute rejection, death and graft loss	24 months
The incidence of de novo donor-specific antibody	24 months

Countries

United States

Contacts

STUDY_DIRECTORTracy Killingsworth

Nefro Avillion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026