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TerminatedNCT04803006Updated Feb 6, 2026

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

A Phase 2 interventional study of TCD601 in Kidney Transplantation, sponsored by ITB-Med LLC. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by ITB-Med LLC · Phase 2, Interventional, and Treatment

Why this study was terminated
Sponsor decision, indication no longer under evaluation
Phase
Phase 2
Study type
Interventional
Enrollment
4
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Kidney Transplantation
03

In context

Lead sponsor

ITB-Med LLC is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Arm 1

    TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

    Biological: TCD601

  • Experimental
    Arm 2

    TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

    Biological: TCD601

Interventions

  • BiologicalTCD601

    Investigational Product

06

What researchers measure

Primary outcomes

  1. The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome

    The proportion of patients off immunosuppression with good safety and tolerability

    Time frame: 24 months

Secondary outcomes

  1. The incidence of biopsy proven acute rejection, death and graft loss

    Time frame: 24 months

  2. The incidence of de novo donor-specific antibody

    Time frame: 24 months

07

Study locations

1 site
  • Columbia University Irving Medical Center
    New York, New York 10032, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04803006
Lead sponsor
ITB-Med LLC
Responsible party
Sponsor
First posted
Mar 17, 2021
Start date
Jan 17, 2023
Primary completion
Oct 30, 2025
Completion
Oct 30, 2025
Last update
Feb 6, 2026

Study contacts

Tracy Killingsworth
study director · Nefro Avillion

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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