This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for adult, de novo, living donor renal transplant recipients.
Donor-Alloantigen-Reactive Regulatory T Cell (darTreg) Therapy in Renal Transplantation: A ONE Study Clinical Trial
A single-center, open-label, dose-escalation pilot trial of a single infusion of darTregs in two dosing cohorts. This study is an independent single-center clinical trial. However, the organizational and mechanistic infrastructure of the study will be provided by the ONE Study project, a European Union funded collaborative project, whose objective is to assess distinct purified hematopoietic immunoregulatory cells as clinical therapies in solid organ transplantation. This study is one of multiple clinical trials within the framework of The ONE Study project, based on the same general design.
Open to people ages 18 years to 70 years
(organ donor eligibility)
Signed and dated written informed consent*. *For subjects unable to read and/or write, oral informed consent observed by an independent witness is acceptable if the subject has fully understood oral information given by the Investigator. The witness should sign the consent form on behalf of the subject.
In signing the donor information sheet/informed consent form (DIS/ICF), organ donors agree to undergo phlebotomy to provide donor B cells for the production of darTreg, to provide a blood sample for the IM Subproject, and permit access to their medical records for the collection of specified demographic and medical/biological data for the trial.
Organ Recipient eligibility:
A prospective kidney transplant recipient is eligible for enrollment into the study if all of the following inclusion criteria apply:
Signed and dated written informed consent*.
If a prospective donor fulfills any of the following criteria, they are ineligible for the trial:
Exclusion criteria (organ recipient)
Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).
Exclusion Criteria B (organ recipient)
Below are exclusion criteria to be assessed post-transplantation and prior to darTreg infusion. Subjects who meet any of these criteria should not receive a darTreg-infusion:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02244801.
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