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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 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.

Find a Location

Who is running the clinical trial?

California Institute for Regenerative Medicine (CIRM)OTHER
65 Previous Clinical Trials
3,145 Total Patients Enrolled
Medeor Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
5 Total Patients Enrolled
Suzanne Crowley, MS, BSNStudy DirectorMedeor Therapeutics
3 Previous Clinical Trials
5 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
~4 spots leftby Jun 2025
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