TCD601 for Kidney Transplant Tolerance

(PERSPECTIVE Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: ITB-Med LLC

Disqualifiers: Cancer, Anti-HLA DSA, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing TCD601 to help new kidney transplant patients from living donors accept their new organ without immune system rejection.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the drug TCD601 for kidney transplant tolerance?

The research on siplizumab, a component of TCD601, shows it has potential in preventing kidney transplant rejection by targeting specific immune cells. Additionally, similar treatments like Lulizumab have shown success in prolonging kidney graft survival in animal studies, suggesting that TCD601 might also help in improving transplant outcomes. ^{1 2 3 4 5}

Is TCD601 (Siplizumab) safe for human use?

Siplizumab, also known as TCD601, has been tested in humans and chimpanzees, showing few mild and temporary side effects in humans. It was generally well-tolerated, with fewer adverse effects compared to a similar antibody, BTI-322. ^{1 2 6 7 8}

How is the drug TCD601 different from other treatments for kidney transplant tolerance?

TCD601, also known as siplizumab, is unique because it is a humanized monoclonal antibody that targets CD2, a molecule on immune cells, to help prevent kidney transplant rejection. This mechanism is different from other treatments that often target different immune pathways or use a combination of therapies. ^{1 2 4 7 9}

Research Team

Nick Hryciw, MA

Principal Investigator

ITB-MED

Eligibility Criteria

This trial is for adults aged 18 to 60 who are receiving their first or second kidney transplant from a living donor who's at least half-matched genetically and has the same blood type. Participants must understand the study and agree to its terms. Pregnant women, those able to have children, or individuals with a history of cancer cannot join.

Inclusion Criteria

I am between 18 and 60 years old.

Able to understand the study requirements and provide written informed consent before and study assessment is performed.

I have received a kidney transplant from a partially matched living donor.

Exclusion Criteria

Donor-specific antibody

I am a woman who could become pregnant.

I have had cancer before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Conditioning and Treatment

Participants receive TCD601 with non-myeloablative conditioning and standard of care immunosuppression

6-8 weeks

Follow-up

Participants are monitored for safety, tolerability, and activity of the treatment regimen

24 months

Treatment Details

Interventions

• TCD601 (Monoclonal Antibodies)

Trial Overview The trial is testing TCD601 in patients getting new kidneys from living donors. It aims to see if this drug can help patients accept their new organ without the immune system attacking it (called 'tolerance').

Participant Groups

Group I: Arm 1 Experimental Treatment 1 Intervention

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Michigan Ann Arbor, MI

UT Southwestern Medical Center Dallas, TX

Weill Cornell New York, NY

Mayo Clinic Rochester, MN

More Trial Locations

Who Is Running the Clinical Trial?

ITB-Med LLC

Lead Sponsor

Trials

12

Recruited

390+

Findings from Research

Desensitization using carfilzomib and lulizumab in a non-human primate model significantly reduced donor-specific antibodies and improved kidney graft survival, with a median survival time of 64.8 days compared to 5.8 days in control animals.

The treatment shifted the immune system towards a more naive phenotype, maintaining regulatory T cells and increasing naive CD4 T and B cells, although all desensitized subjects eventually developed antibody-mediated rejection (AMR) and graft failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative carfilzomib and lulizumab based desensitization prolongs graft survival in a sensitized non-human primate model. Schroder, PM., Schmitz, R., Fitch, ZW., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Safety profile, pharmacokinetics, and pharmacodynamics of siplizumab, a humanized anti-CD2 monoclonal antibody, in renal allograft recipients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Preoperative carfilzomib and lulizumab based desensitization prolongs graft survival in a sensitized non-human primate model. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Current status of tolerance in kidney transplantation. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Tocilizumab Trough Levels Variability in Kidney-Transplant Candidates Undergoing Desensitization. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Specific alloantigen self-control by regulatory T cells in organ transplantation: a review. [2007]

6. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and pharmacodynamic study of a clinically effective anti-CD2 monoclonal antibody. [2020]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Tocilizumab in the Treatment of Chronic Antibody-Mediated Rejection Post Kidney Transplantation: Clinical and Histological Monitoring. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Report of the inefficacy of eculizumab in two cases of severe antibody-mediated rejection of renal grafts. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Tocilizumab and Active Antibody-Mediated Rejection in Kidney Transplantation: A Literature Review. [2022]