A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation

A 12-Month, Randomized, Controlled, Open-Label, Dose Escalation Study Evaluating Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of an Anti-CD2 Monoclonal Antibody, TCD601 (Siplizumab) Compared to Anti-thymocyte Globulin (rATG), as Induction Therapy in de Novo Renal Transplant Recipients

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.

Study Overview

• Status: Terminated
• Conditions: Kidney Transplantation
• Intervention / Treatment: Biological: TCD601; Drug: Tacrolimus (TAC); Drug: Corticosteroids (CS); Drug: Mycophenolate Mofetil (MMF); Drug: ATG

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria, A-6020
    • Innsbruck Medical University
  • Vienna, Austria, 1090
    • University of Vienna
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic De Barcelona
  • Barcelona, Spain, 08907
    • Hospital Universitari de Bellvitge
• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska University Hospital
  • Malmo, Sweden, 20502
    • Skåne University Hospital
  • Huddinge
    • Stockholm, Huddinge, Sweden, 14157
      • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 70 years of age.
• Recipients of a de novo renal allograft from a heart-beating deceased, living unrelated, or non-HLA identical living related donor.
• Recipients of a kidney with a cold ischemia time (CIT) less than 30 hours.

Exclusion Criteria:

• Multiple-organ transplant recipients
• Subjects who have received a kidney allograft previously
• Recipient of a kidney from an HLA identical living related donor
• Recipient of a kidney from a donor after cardiac death
• Subjects at high immunological risk for rejection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; TCD601 0.2 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).	Biological: TCD601; Investigational Product; Other Names: Siplizumab; Drug: Tacrolimus (TAC); Standard of Care Concomitant Immunosuppression; Drug: Corticosteroids (CS); Standard of Care Concomitant Immunosuppression; Drug: Mycophenolate Mofetil (MMF); Standard of Care Concomitant Immunosuppression
Experimental: Arm 2; TCD601 0.6 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).	Biological: TCD601; Investigational Product; Other Names: Siplizumab; Drug: Tacrolimus (TAC); Standard of Care Concomitant Immunosuppression; Drug: Corticosteroids (CS); Standard of Care Concomitant Immunosuppression; Drug: Mycophenolate Mofetil (MMF); Standard of Care Concomitant Immunosuppression
Experimental: Arm 3; TCD601 1.7 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).	Biological: TCD601; Investigational Product; Other Names: Siplizumab; Drug: Tacrolimus (TAC); Standard of Care Concomitant Immunosuppression; Drug: Corticosteroids (CS); Standard of Care Concomitant Immunosuppression; Drug: Mycophenolate Mofetil (MMF); Standard of Care Concomitant Immunosuppression
Experimental: Arm 4; TCD601 5.0 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).	Biological: TCD601; Investigational Product; Other Names: Siplizumab; Drug: Tacrolimus (TAC); Standard of Care Concomitant Immunosuppression; Drug: Corticosteroids (CS); Standard of Care Concomitant Immunosuppression; Drug: Mycophenolate Mofetil (MMF); Standard of Care Concomitant Immunosuppression
Active Comparator: Arm 5; ATG 1.5 mg/kg administered with the contemporary standard of care (SoC) consisting of concentration-controlled tacrolimus (TAC) combined with mycophenolate mofetil (MMF) and corticosteroids (CS).	Drug: Tacrolimus (TAC); Standard of Care Concomitant Immunosuppression; Drug: Corticosteroids (CS); Standard of Care Concomitant Immunosuppression; Drug: Mycophenolate Mofetil (MMF); Standard of Care Concomitant Immunosuppression; Drug: ATG; Standard of Care induction therapy in solid organ transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0.		12 months
Measure Peak TCD601 Plasma Concentration (Cmax) Over Time.	The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.	12 months
Measure the Area Under the TCD601 Plasma Concentration Versus Time Curve (AUC).	The AUC from time zero to the last measurable concentration sampling time.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The Incidence of Allograft Rejection at 12 Months Post-Transplant	12 months
To Assess Renal Function Over Time	12 months

Collaborators and Investigators

• Sponsor: ITB-Med LLC
• Investigators: Study Director: Fredrik Juhlin, ITB-Med LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Actual): December 11, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Organic Chemicals; Fatty Acids; Lipids; Acids, Acyclic; Carboxylic Acids; Macrolides; Lactones; Caproates; Mycophenolic Acid; Tacrolimus; Adrenal Cortex Hormones; siplizumab
• Other Study ID Numbers: TCD601B101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No