Kidney Failure, Kidney TransplantPhase 1NCT02091232
Infusion of T-Regulatory Cells in Kidney Transplant Recipients (The ONE Study)
A Phase 1 study testing T Regulatory Cell Infusion in people with Kidney Failure, Kidney Transplant, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research study is for patients who are going to receive a kidney transplant from a living donor. After kidney transplantation, it is necessary for transplant recipients to take "immunosuppressive drugs". These drugs work by preventing the body's immune cells from attacking and "rejecting" the new kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Kidney Transplant
- What is being tested?
- T Regulatory Cell Infusion
- Type of treatment
- Injection or infusion
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to 2 Mar 2016
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Key Recipient Inclusion Criteria:
- Chronic renal insufficiency necessitating kidney transplantation
- Aged at least 18 years
- Donor is ABO (Blood type) compatible
Key Recipient Exclusion Criteria:
- HIV positive, EBV negative, or suffering from chronic viral hepatitis or tuberculosis
- Previously received any tissue or organ transplant other than planned kidney graft
- Genetically identical to the prospective organ donor at the HLA loci (0-0-0 mismatch)
- Panel Reactive Antibodies (PRA) >20%
- Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non metastatic basal/squamous cell carcinoma of the skin)
- Ongoing treatment with systemic immunosuppressive drugs at study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Renal Transplantation Followed By Infusion of T-Regulatory Cells Made With Belatacept Ex-Vivo
This research study is for patients who are going to receive a kidney transplant from a living donor. After kidney transplantation, it is necessary for transplant recipients to take "immunosuppressive drugs". These drugs work by preventing the body's immune cells from attacking and "rejecting" the new kidney. Taking these drugs long-term may also cause harm to the transplanted kidney. Therefore, the transplant community is very interested in finding ways to decrease immunosuppressive drug treatment and further reduce the risk of kidney rejection. One method to do so is known as "induction of tolerance", which is when the person who receives a transplant has treatment to make their immune cells tolerant to the donor cells.
In this study, we will try to induce tolerance by mixing recipient cells and their donor's cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that attaches to immune system cells, interferes with the immune response and results in tolerance induction.
Read more
After we mix the recipient cells with the donor's cells, we will sort out one particular kind of immune cell, called a regulatory T cell, and inject them back into the recipient. Regulatory T cells are the cells that are affected by induction to reduce rejection of donated organs. This method for inducing tolerance has been used in bone marrow transplantation, but this is the first time it is being done in kidney transplantation.
This study is being conducted as part of a unique collaboration of US and EU centers called The ONE Study. The ONE Study centers have agreed to work together using common protocols and procedures but with each testing their own regulatory population for safety and the ability to promote kidney survival. Sharing data among the participating sites will permit a deeper understanding of how and why some treatments might succeed while others work less well.
- Conditions
- Kidney Failure, Kidney Transplant
- Being tested
- T Regulatory Cell Infusion
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T Regulatory Cell InfusionBiological
After blood is collected from the donor and recipient, the facility will sort out one particular kind of immune cell called a regulatory T cell which is strongly influenced by tolerance induction to minimize (suppress) responses to the donor cells. In this study, these regulatory T cells are the cells which will be given back to the recipient on Day 7 (+3 days) post-transplant.
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Feasibility of T Regulatory Cell Infusion in Renal Transplantation
To examine in living donor renal transplant recipients the safety and feasibility of administering T regulatory cells derived from recipient PBMC stimulated with kidney donor PBMC in the presence of costimulatory blockade with belatacept.
Measured: 2 Weeks
Secondary outcomes (2)
T-Reg Measurements
To measure the presence, potency, and specificity of Treg in the peripheral circulation of kidney transplant recipients.
This will be done by in-vitro testing of the T-reg cell product and peripheral blood.
Measured: 2 Years
Reduction of Immunosuppression
To develop preliminary information on whether administration of the Treg cell product allows a tapering of conventional maintenance immunosuppression within 60 weeks after transplantation.
Measured: 60 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startMay 2014
- Primary completion2 Mar 2016
- Study completion2 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, University of Regensburg
- Responsible party
- Principal investigator, James F. Markmann, MD, PhD, Massachusetts General Hospital
- Investigators
- Jim Markmann, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091232
- Sponsor's protocol ID
- The ONE Study
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2014
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Boger CA, Scotta C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Ollinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyo J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7.
PubMed 32446407Guinan EC, Cole GA, Wylie WH, Kelner RH, Janec KJ, Yuan H, Oppatt J, Brennan LL, Turka LA, Markmann J. Ex Vivo Costimulatory Blockade to Generate Regulatory T Cells From Patients Awaiting Kidney Transplantation. Am J Transplant. 2016 Jul;16(7):2187-95. doi: 10.1111/ajt.13725. Epub 2016 Mar 11.
PubMed 26790369
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Transplantation Followed By Infusion of T-Regulatory Cells Made With Belatacept Ex-Vivo
- ClinicalTrials.gov ID
- NCT02091232
- Acronym / sponsor ID
- The ONE Study
- Conditions
- Kidney Failure, Kidney Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, University of Regensburg
- Study start
- May 2014
- Primary completion
- 2 Mar 2016 (actual)
- Study completion
- 2 Mar 2016 (actual)
- First posted
- 19 Mar 2014 (estimated)
- 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.
This research study is for patients who are going to receive a kidney transplant from a living donor. After kidney transplantation, it is necessary for transplant recipients to take "immunosuppressive drugs". These drugs work by preventing the body's immune cells from attacking and "rejecting" the new kidney. Taking these drugs long-term may also cause harm to the transplanted kidney. Therefore, the transplant community is very interested in finding ways to decrease immunosuppressive drug treatment and further reduce the risk of kidney rejection. One method to do so is known as "induction of tolerance", which is when the person who receives a transplant has treatment to make their immune cells tolerant to the donor cells.
In this study, we will try to induce tolerance by mixing recipient cells and their donor's cells together with belatacept, an immunosuppressive drug. Belatacept is a protein that attaches to immune system cells, interferes with the immune response and results in tolerance induction.
After we mix the recipient cells with the donor's cells, we will sort out one particular kind of immune cell, called a regulatory T cell, and inject them back into the recipient. Regulatory T cells are the cells that are affected by induction to reduce rejection of donated organs. This method for inducing tolerance has been used in bone marrow transplantation, but this is the first time it is being done in kidney transplantation.
This study is being conducted as part of a unique collaboration of US and EU centers called The ONE Study. The ONE Study centers have agreed to work together using common protocols and procedures but with each testing their own regulatory population for safety and the ability to promote kidney survival. Sharing data among the participating sites will permit a deeper understanding of how and why some treatments might succeed while others work less well.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| T Regulatory Cell InfusionAfter blood is collected from the donor and recipient, the facility will sort out one particular kind of immune cell called a regulatory T cell which is strongly influenced by tolerance induction to minimize (suppress) responses to the donor cells. In this study, these regulatory T cells are the cells which will be given back to the recipient on Day 7 (+3 days) post-transplant. | Biological | – |
Primary outcome
Safety and Feasibility of T Regulatory Cell Infusion in Renal Transplantation
Time frame: 2 Weeks
To examine in living donor renal transplant recipients the safety and feasibility of administering T regulatory cells derived from recipient PBMC stimulated with kidney donor PBMC in the presence of costimulatory blockade with belatacept.
2 secondary outcomes
T-Reg Measurements
Time frame: 2 Years
Reduction of Immunosuppression
Time frame: 60 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 32446407Sawitzki B, Harden PN, Reinke P, Moreau A, Hutchinson JA, Game DS, Tang Q, Guinan EC, Battaglia M, Burlingham WJ, Roberts ISD, Streitz M, Josien R, Boger CA, Scotta C, Markmann JF, Hester JL, Juerchott K, Braudeau C, James B, Contreras-Ruiz L, van der Net JB, Bergler T, Caldara R, Petchey W, Edinger M, Dupas N, Kapinsky M, Mutzbauer I, Otto NM, Ollinger R, Hernandez-Fuentes MP, Issa F, Ahrens N, Meyenberg C, Karitzky S, Kunzendorf U, Knechtle SJ, Grinyo J, Morris PJ, Brent L, Bushell A, Turka LA, Bluestone JA, Lechler RI, Schlitt HJ, Cuturi MC, Schlickeiser S, Friend PJ, Miloud T, Scheffold A, Secchi A, Crisalli K, Kang SM, Hilton R, Banas B, Blancho G, Volk HD, Lombardi G, Wood KJ, Geissler EK. Regulatory cell therapy in kidney transplantation (The ONE Study): a harmonised design and analysis of seven non-randomised, single-arm, phase 1/2A trials. Lancet. 2020 May 23;395(10237):1627-1639. doi: 10.1016/S0140-6736(20)30167-7.
- Derived from this study: PubMed 26790369Guinan EC, Cole GA, Wylie WH, Kelner RH, Janec KJ, Yuan H, Oppatt J, Brennan LL, Turka LA, Markmann J. Ex Vivo Costimulatory Blockade to Generate Regulatory T Cells From Patients Awaiting Kidney Transplantation. Am J Transplant. 2016 Jul;16(7):2187-95. doi: 10.1111/ajt.13725. Epub 2016 Mar 11.
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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.
Jim Markmann, MD PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T Regulatory Cell Infusion in people with Kidney Failure, Kidney Transplant, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety and Feasibility of T Regulatory Cell Infusion in Renal Transplantation (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091232, which also lists 2 linked publications.
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 29 Mar 2024.