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

Kidney Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06365437
• Other study ID #: TCD601B101
• Status: Recruiting
• Phase: Phase 2
• Start date: June 6, 2021
• Est. completion date: August 2025

Study information

• Verified date: April 2024
• Source: ITB-Med LLC
• Contact: Jesse Scott, MPH
• Phone: 212-969-7823
• Email: jesse.scott[@]itb-med.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Biological:
• TCD601
Investigational Product

Drug:
• Tacrolimus (TAC)
Standard of Care Concomitant Immunosuppression
• Corticosteroids (CS)
Standard of Care Concomitant Immunosuppression
• Mycophenolate Mofetil (MMF)
Standard of Care Concomitant Immunosuppression
• ATG
Standard of Care induction therapy in solid organ transplantation

Locations

Country	Name	City	State
Austria	Innsbruck Medical University	Innsbruck
Austria	University of Vienna	Vienna
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari de Bellvitge	Barcelona
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Skåne University Hospital	Malmö
Sweden	Karolinska University Hospital	Stockholm	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
ITB-Med LLC

Countries where clinical trial is conducted

Austria,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.		12 months
Primary	Measure Peak Plasma Concentration (Cmax) over time.	The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration.	12 months
Primary	Measure the Area under the plasma concentration versus time curve (AUC).	The AUC from time zero to the last measurable concentration sampling time.	12 months
Secondary	Assess changes in peripheral immunophenotype, including T-, B-, and NK-cells, via Fluorescence-activated Cell Sorter (FACS) over time.		12 months
Secondary	Measure anti-TCD601 antibodies in serum via Enzyme-linked Immunosorbent (ELISA) assay over time.		12 months
Secondary	Measure peripheral CD2-receptor occupancy following TCD601 administration Receptor Occupancy will be reported as the % of target saturation.		12 months