Kidney Transplant RejectionPhase 2NCT03606746
Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor Kidney Transplants
A Phase 2 study testing MDR-103 in people with Kidney Transplant Rejection, run by Medeor Therapeutics, Inc..
Trial summary
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Transplant Rejection
- What is being tested?
- MDR-103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Oct 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient Inclusion Criteria:
- Past recipient of a first kidney allograft from an HLA-matched, living related donor
- Age ≥18 and ≤70 years
- Single solid organ recipient (kidney only)
- ABO compatibility with donor
- Donor Inclusion Criteria:
Show all 9Show fewer
- HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling, half sibling) relative of the prospective recipient participant
- Age ≥18 and ≤70 years
- Past living related kidney donor, and capable of undergoing G-CSF mobilization and apheresis of hematopoietic cells
Who cannot join
- Recipient Exclusion Criteria:
- Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
- Baseline positive donor-specific anti-HLA antibody testing
- Is taking immunosuppressive therapy
- Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)
- Donor Exclusion Criteria:
Show all 10Show fewer
- History of autoimmune disorders
- History of type 1 or type 2 diabetes mellitus
- Tests confirmed positive for human immunodeficiency virus (HIV), HBV, HCV
- History of infection with Zika virus
About this study
Official title: A Phase 2 Prospective, Multi-center, Open-label Trial to Assess the Safety & Efficacy of Cellular Immunotherapy With MDR-103 for Induction of Mixed Chimerism & Immune Tolerance in Past Recipients of HLA Zero-mismatch, LD Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.
Read the detailed description
Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the past recipients' immune system to accept the transplanted kidney without the concurrent need for long term use of immunosuppressive drugs.
The purpose of the current Phase 2 study is to demonstrate the efficacy and safety of MDR-103 for the induction of transplant immune tolerance in a prospective, multicenter clinical trial. MDR-103 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.
- Conditions
- Kidney Transplant Rejection
- Being tested
- MDR-103
- Keywords
- Kidney Transplant, Kidney Failure, Anti-rejection therapy, Living Donor, HLA-matched, Hematopoietic Stem Cells (HSC), CD34+, CD3+, T cells, Cellular Therapy, Immunotherapy, Immunosuppression
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDR-103Biological
MDR-103 Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
| Study group | Role | What they receive |
|---|---|---|
| Investigational Arm | Experimental | A low-dose Total Lymphoid Irradiation (TLI) and anti-thymocyte globulin (ATG) combined with a single IV infusion of MDR-103 and standard anti-rejection medications in past recipients of HLA Zero-mismatch living donor kidney transplants. Receives: Biological: MDR-103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Persistent Mixed Chimerism
The primary efficacy endpoint is the proportion of subjects achieving persistent mixed chimerism in MDR-103 treated recipients of past HLA zero-mismatch living donor kidney transplants.
Persistent Mixed Chimerism - is defined as at least 6 months of persistent WBC mixed chimerism consisting of at least 5% donor cells in whole blood or in at least one WBC lineage (CD3+ T cells, CD33+ myeloid cells, CD19+ B cells, and/or CD56+ NK cells).
Measured: At 6 months post initiation of anti-thymocyte globulin (ATG) conditioning therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study startDec 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionOct 2025 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medeor Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606746
- Sponsor's protocol ID
- MDR-103-L2K
- Status last verified
- Jun 2024
- First submitted
- 20 Jul 2018
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Prospective, Multi-center, Open-label Trial to Assess the Safety & Efficacy of Cellular Immunotherapy With MDR-103 for Induction of Mixed Chimerism & Immune Tolerance in Past Recipients of HLA Zero-mismatch, LD Kidney Transplants
- ClinicalTrials.gov ID
- NCT03606746
- Acronym / sponsor ID
- MDR-103-L2K
- Conditions
- Kidney Transplant Rejection
- Keywords
- Kidney Transplant, Kidney Failure, Anti-rejection therapy, Living Donor, HLA-matched, Hematopoietic Stem Cells (HSC), CD34+, CD3+
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medeor Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-103 for induction of functional immune tolerance in past recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.
Detailed description
Currently, patients receiving a transplanted kidney are required to take life-long immunosuppressive medications to prevent rejection of the transplanted kidney. These medications carry substantial side effects. In addition, these medicines often do not completely control damage to the kidney from the recipients' immune system, ultimately causing the kidney to fail.
Medeor Therapeutics is developing a novel cell-based therapy to reprogram the past recipients' immune system to accept the transplanted kidney without the concurrent need for long term use of immunosuppressive drugs.
The purpose of the current Phase 2 study is to demonstrate the efficacy and safety of MDR-103 for the induction of transplant immune tolerance in a prospective, multicenter clinical trial. MDR-103 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Arm | Experimental | Biological: MDR-103A low-dose Total Lymphoid Irradiation (TLI) and anti-thymocyte globulin (ATG) combined with a single IV infusion of MDR-103 and standard anti-rejection medications in past recipients of HLA Zero-mismatch living donor kidney transplants. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Past recipient of a first kidney allograft from an HLA-matched, living related donor
- Age ≥18 and ≤70 years
- Single solid organ recipient (kidney only)
- ABO compatibility with donor
- HLA-matched first degree (parent, child or sibling) or second-degree (child of a sibling, half sibling) relative of the prospective recipient participant
Key exclusion criteria (10 listed)
- Underlying kidney disease with a high risk of disease recurrence in the transplanted kidney
- Baseline positive donor-specific anti-HLA antibody testing
- Is taking immunosuppressive therapy
- Evidence of prior hepatitis B (HBV) or hepatitis C (HCV)
- History of autoimmune disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDR-103MDR-103 Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells | Biological | Investigational Arm |
Primary outcome
Persistent Mixed Chimerism
Time frame: At 6 months post initiation of anti-thymocyte globulin (ATG) conditioning therapy
The primary efficacy endpoint is the proportion of subjects achieving persistent mixed chimerism in MDR-103 treated recipients of past HLA zero-mismatch living donor kidney transplants. Persistent Mixed Chimerism - is defined as at least 6 months of persistent WBC mixed chimerism consisting of at least 5% donor cells in whole blood or in at least one WBC lineage (CD3+ T cells, CD33+ myeloid cells, CD19+ B cells, and/or CD56+ NK cells).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MDR-103 in people with Kidney Transplant Rejection, run by Medeor Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistent Mixed Chimerism (time frame: At 6 months post initiation of anti-thymocyte globulin (ATG) conditioning therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.