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Monoclonal Antibodies

TCD601 for Kidney Transplant Rejection Prevention

Phase 2
Recruiting
Research Sponsored by ITB-Med LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients ≥ 18 to 60 years of age
Recipient of a first or second renal transplant from a non-HLA identical, but at least haploidentical, ABO compatible living donor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial will test how well a new drug works in combination with bone marrow cells from a donor to help prevent organ rejection in people who have recently received a kidney transplant.

Who is the study for?
This trial is for adults aged 18-60 who are receiving their first or second kidney transplant from a living donor who's at least a half-match. Participants must understand the study and agree to its terms. People with cancer, specific donor antibodies, or women able to have children cannot join.Check my eligibility
What is being tested?
The PANORAMA study is testing TCD601 (siplizumab) combined with bone marrow cells from the donor and a special conditioning treatment in new kidney transplant patients to see if it helps them accept the organ without long-term immune suppression.See study design
What are the potential side effects?
Potential side effects of siplizumab may include allergic reactions, increased risk of infections due to immune system suppression, possible infusion-related reactions, and other effects that could impact organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 60 years old.
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I have received a kidney transplant from a partially matched living donor.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome
Secondary outcome measures
The incidence of biopsy proven acute rejection, death and graft loss
The incidence of de novo donor-specific antibody

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3Experimental Treatment1 Intervention
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Group II: Arm 2Experimental Treatment1 Intervention
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Group III: Arm 1Experimental Treatment1 Intervention
TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TCD601
2021
Completed Phase 2
~20

Find a Location

Who is running the clinical trial?

ITB-Med LLCLead Sponsor
9 Previous Clinical Trials
313 Total Patients Enrolled
Nick Hryciw, MAStudy DirectorITB-MED
3 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

TCD601 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04803006 — Phase 2
Kidney Transplant Research Study Groups: Arm 1, Arm 2, Arm 3
Kidney Transplant Clinical Trial 2023: TCD601 Highlights & Side Effects. Trial Name: NCT04803006 — Phase 2
TCD601 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04803006 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still ongoing for this experiment?

"Affirmative, the records on clinicaltrials.gov attest to this trial being open for recruitment. It was initially publicized on January 1st 2023 and most recently modified on October 28th 2022. A total of 18 people need to be enrolled at 6 different sites."

Answered by AI

How many participants are engaged in this experiment?

"ITB-Med LLC, the sponsor of this experiment, will be performing it at Cooperman Barnabas Medical Center in Livingston and Saint Barnabas Medical Centre in New york. In order to execute the trial successfully, 18 participants that meet all inclusion criteria must enroll."

Answered by AI

What is the geographic breadth of this clinical trial's implementation?

"This research project is currently running at Cooperman Barnabas Medical Center in Livingston, Saint Barnabas Medical Center in New york, and NYU Langone in Baltimore. There are 3 other sites actively participating as well."

Answered by AI

Is the upper age limit for enrollment into this research trial twenty years or older?

"According to the study's eligibility guidelines, individuals between 18 and 60 years of age are eligible for inclusion in this clinical trial."

Answered by AI

Who is eligible to be a participant in this medical experiment?

"Those wishing to become involved in this medical experiment must have healthy kidneys and be within the bracket of 18-60 years old. The total number of recruits needed is 18 individuals."

Answered by AI

Does TCD601 pose any risks to human health?

"The safety of TCD601 was appraised as a 2, since the trial is currently on Phase 2. Current data suggests that its use can be secure, but there isn't sufficient evidence yet to confirm its efficacy."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PANORAMA)
2023. "A Study of TCD601 in the Induction of Tolerance in de Novo Renal Transplantation (PANORAMA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04803006.
~12 spots leftby Jan 2027
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