A Phase 1 interventional study of darTreg infusion in Kidney Disease, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-15.
Sponsored by University of California, San Francisco · Phase 1, Interventional, and Treatment
This Phase I pilot study will evaluate the safety, and tolerability of darTreg infusion for adult, de novo, living donor renal transplant recipients.
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: (organ donor eligibility)
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*.
Exclusion Criteria: (organ donor)
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:
3 subjects treated with a target dose of 300 million darTreg with the possibility of expanding to 5 patients if safety signals should require additional patients be observed at the 300 million dose. The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients.
Drug: darTreg infusion
The second cohort will comprise a minimum of 3 and up to 5 subjects treated at a target dose of 900 million darTreg, depending on how many patients were required to be treated in lower dose group. The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients.
Drug: darTreg infusion
The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. sBc production for darTreg manufacturing for the second subject in each cohort may be initiated but the second subject may not undergo leukapheresis until the safety review is complete. Once the last subject in the first cohort reaches week 4 post-infusion, the DSMB will conduct a thorough review of all available data to make a determination about proceeding with additional patients at the lower dose or proceeding to the second dosing cohort. sBc production for darTreg manufacturing for the subsequent subject may be initiated but the patient may not undergo leukapheresis until the DSMB( Data Safety and Monitoring Board ) has approved enrollment of subsequent subjects.
Also known as: darTregs
Incidence of biopsy-confirmed acute rejection (BCAR) following renal transplantation.
Explore the immunomodulatory potential, safety and tolerability of a single infusion of darTregs as adjunct immunosuppressive treatment through the incidence of biopsy-confirmed acute rejection (BCAR) within 60 weeks following renal transplantation.
Time frame: 60 weeks post renal transplantation
Time to first acute rejection episode
Time frame: 60 weeks post renal transplantation
Severity of acute rejection episodes
severity of acute rejection episodes based on response to treatment and histological scoring
Time frame: 60 weeks post renal transplantation
Total immunosuppressive burden at 60 weeks post-transplantation
Total immunosuppressive burden assessed at last study visit
Time frame: 60 weeks post renal transplantation
Prevention of chronic graft dysfunction (chronic rejection or IF/TA)
chronic graft dysfunction assessed by clinical (impairment of GFR) and histopathological (Banff staging) measures
Time frame: 60 weeks post renal transplantation
Incidence of post-transplant dialysis, inclusion on the transplant waiting list or re-transplantation following graft loss through rejection
Time frame: 60 weeks post renal transplantation
Avoidance of drug-related complications by immunosuppressant reduction
Assessed by the incidence of reported adverse drug reactions
Time frame: 60 weeks post renal transplantation
Biochemical disturbances caused by cell infusion
Assessed by Incidence of acute toxicities associated with infusion of the cell product
Time frame: 1 week
Over-suppression of the immune system assessed by the incidence of major and/or opportunistic infections especially CMV (cytomegalovirus ), EBV (Epstein-Barr virus) and polyoma virus
Time frame: 60 weeks post renal transplantation
Incidence of neoplasia
Time frame: 60 weeks post renal transplantation
Incidence of patients treated for subclinical acute rejection
Time frame: 60 weeks post transplantation
Incidence of malignancies arising directly from darTreg infusion
Time frame: 60 weeks
incidence of autoimmune disorders
Time frame: 60 weeks post transplantation
A Health-Economics Subproject will evaluate the health-related qualify-of-life of trail patients using patient-reported outcome measures
Time frame: 60 weeks post transplantation
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco