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CAR T-cell Therapy

Immunotherapy (MDR-101) for Kidney Transplant Rejection

Phase 3

Waitlist Available

Research Sponsored by Medeor Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Single solid organ recipient (kidney only)

ABO matched with donor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months post-kidney transplant

Awards & highlights

Study Summary

This trial will test a new immunotherapy drug to see if it is safe and effective in preventing organ rejection in people who have received a kidney transplant from a living donor.

Who is the study for?

This trial is for adults aged 18-70 who are getting their first kidney transplant from a living relative with matching blood type and human leukocyte antigen (HLA). It's not open to those receiving multiple organs or previous transplant recipients.Check my eligibility

What is being tested?

The study is testing MDR-101, a cellular immunotherapy treatment, to see if it can safely prevent the body from rejecting a matched, living donor kidney transplant by inducing immune tolerance.See study design

What are the potential side effects?

While specific side effects of MDR-101 aren't listed here, similar treatments may cause reactions at the infusion site, flu-like symptoms, risk of infection, and possible impact on white blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have received a kidney transplant.

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My blood type matches with the donor's.

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I am ready and able to donate a kidney and undergo procedures to collect stem cells.

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I am scheduled to receive my first kidney transplant from a related donor who matches my tissue type.

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I am between 18 and 70 years old.

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I have a relative who matches me closely for a medical procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months post-kidney transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months post-kidney transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months post-kidney transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Functional immune tolerance defined as

Trial Design

2Treatment groups

Active Control

Group I: MDR-101Active Control1 Intervention

A single dose will be administered via IV infusion post-kidney transplant.

Group II: Control ArmActive Control1 Intervention

Subjects randomized to this arm will receive the standard anti-rejection medications that would be given to kidney transplant recipients who are outside the study.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

California Institute for Regenerative Medicine (CIRM)OTHER

63 Previous Clinical Trials

3,118 Total Patients Enrolled

Medeor Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

247 Total Patients Enrolled

Suzanne Crowley, MS, BSNStudy DirectorMedeor Therapeutics

3 Previous Clinical Trials

247 Total Patients Enrolled

Media Library

MDR-101 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03363945 — Phase 3

Kidney Transplant Rejection Research Study Groups: MDR-101, Control Arm

Kidney Transplant Rejection Clinical Trial 2023: MDR-101 Highlights & Side Effects. Trial Name: NCT03363945 — Phase 3

MDR-101 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03363945 — Phase 3

Frequently Asked Questions

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

Are researchers looking for participants who are at least 18 years old for this clinical trial?

"This clinical trial is enrolling candidates who are of legal age and below 70 years old."

Answered by AI

Which type of patient is this research most applicable to?

"The ideal candidate for this study would have a history of rejection; specifically, they should have had a kidney transplant. In addition, they should be between 18 and 70 years old. Right now, the study is looking to recruit a total of 30 people."

Answered by AI

Can you list the hospitals where this trial is taking place?

"So far, 20 patients have been recruited for this clinical trial at locations including University of California San Diego Moores Cancer Center in La Jolla, University Hospitals Cleveland Medical Center in Cleveland, and Loma Linda University Medical Center in Loma Linda. There are 20 other locations still recruiting."

Answered by AI

Are new patients still being taken in for this research project?

"The trial in question appears to be inactive, according to the clinicaltrials.gov website. This study was posted on March 15, 2018 and last updated on August 22, 2020. There are, however, 31 other trials that are open for recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants

2018. "Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03363945.

All > Kidney Transplant