Clinical trials: Cellular Rejection
Kidney Transplant Rejection
Cellular Immunotherapy in Recipients of HLA-matched, Living Donor Kidney Transplants
The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living…
- Trial name
- NCT03363945
- Testing
- MDR-101
- Where
- 19 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Medeor Therapeutics, Inc.
Kidney Transplant Rejection, End Stage Renal Disease
Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.
- Trial name
- NCT05987527
- Testing
- Blood sample
- Where
- 5 sites in Belgium, Netherlands and 1 more
- Volunteers
- 11 people
- Sponsor
- Sangamo Therapeutics
Kidney Transplant Recipients
Non Invasive Blood Test To Diagnose Acute Rejection After Kidney Transplantation
This is a prospective, multicenter, observational study of kidney transplant subjects where blood specimens, intended for dd-cfDNA and other future research purposes, will be drawn after transplant
- Trial name
- DART (NCT02424227)
- Where
- 14 sites in United States
- Volunteers
- 401 people
- Sponsor
- CareDx
Transplant Rejection, Transplant Kidney
Study of the Plasma and Urinary cfDNA of in Kidney Transplant Patients
It has been shown that the amount of circulating donor-cell-free DNA increases in patients with transplant rejection. Quantification of single nucleotide polymorphisms (SNPs) present in circulating donor DNA currently allows for…
- Trial name
- PLAKID-TRANSP (NCT06910527)
- Where
- France
- Volunteers
- 250 people
- Sponsor
- Poulet Geoffroy
Kidney Diseases, Kidney Injury
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
To evaluate the association between time-updated CMV and BK viral loads measured monthly by T-ID and the risk of CMV disease and/or biopsy-proven BK virus-associated nephropathy (BKVAN) during the first 12 months following kidney…
- Conditions
- Kidney Diseases, Kidney Injury, BK Virus Infection, CMV
- Trial name
- ID-ENTITY (NCT07393594)
- Testing
- Blood tests, TRAC( cell free DNA) and T-ID
- Where
- 14 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Transplant Genomics, Inc.
Kidney Transplant Rejection
Cellular Immunotherapy for Immune Tolerance in Past Recipients of HLA Zero-mismatch, Living Donor 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…
- Trial name
- NCT03606746
- Testing
- MDR-103
- Sponsor
- Medeor Therapeutics, Inc.
Heart Transplant Rejection
Heartsbreath Test for Heart Transplant Rejection
The purpose of this study is to demonstrate and validate a breath test for detection of biomarkers of heart transplant rejection (Grade 2R heart transplant).
- Trial name
- Heartsbreath (NCT01397812)
- Testing
- BreathScanner 1.0, BreathLink
- Where
- 5 sites in United States
- Volunteers
- 1,200 people
- Sponsor
- Menssana Research, Inc.
Kidney Transplant Rejection, Cell-free DNA
Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring
The goal of this observational study is to learn if the donor-derived cell-free DNA (dd-cfDNA) test can assess rejection in kidney transplant recipients. Participants will have blood and urine collected at their study visit.
- Trial name
- NCT07060716
- Testing
- donor-derived cell-free DNA test
- Where
- 10 sites in United States, Germany
- Volunteers
- 125 people
- Sponsor
- Insight Molecular Diagnostics
Kidney Transplant Rejection
Cellular Immunotherapy in Recipients of Human Leukocyte Antigen (HLA)-Mismatched, Living Donor Kidney Transplants
The Phase 2 primary objective is to evaluate achievement of persistent mixed chimerism and withdrawal of at least one immunosuppression drug for a minimum of 6 months with no episodes of biopsy-proven acute rejection or…
- Trial name
- NCT03605654
- Testing
- MDR-102, Immunosuppressive Agents
- Sponsor
- Medeor Therapeutics, Inc.
Cardiac Transplant Failure, Cardiac Transplant Rejection
Utility of Donor-Derived Cell Free DNA in Association With Gene Expression Profiling
Plasma donor-derived cell-free DNA (dd-cfDNA) is measured as a % of the total plasma cfDNA in association with the measurement of AlloMap, a non-invasive gene expression test to aid in heart transplant management.
- Conditions
- Cardiac Transplant Failure, Cardiac Transplant Rejection, Heart Diseases
- Trial name
- D-OAR (NCT02178943)
- Where
- 28 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- CareDx
Autoimmune Diseases, Inflammation
Prospective Study of White Blood Cells
The purpose of this study is to investigate white blood cells from volunteering donors to support the development of engineered regulatory T cell therapies.
- Conditions
- Autoimmune Diseases, Inflammation, Rejection; Transplant, Liver
- Trial name
- NCT04838171
- Testing
- White blood cell and blood collection
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Quell Therapeutics Limited
Heart Transplant Failure and Rejection
A Comparative Effectiveness Study in Heart Transplant Patients of Rejection Surveillance With Cell-free DNA Versus Endomyocardial Biopsy
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.
- Trial name
- ACES-EMB (NCT06414603)
- Testing
- The Prospera™ Test
- Where
- 16 sites in United States
- Volunteers
- 250 people
- Sponsor
- Natera, Inc.
Kidney Transplant
GraftAssure Lowering Allograft rejeCTIon by Combination- (GALACTIC) Trial
The GALACTIC Registry study purpose is to validate the Combination Model-score (CM-score) for increased accuracy in the percentage of the positive predictive value (PPV) of allograft rejection results for the GraftAssure…
- Trial name
- GALACTIC (NCT07551531)
- Where
- United States
- Volunteers
- 5,000 people
- Sponsor
- Insight Molecular Diagnostics
Rejection; Transplant, Liver, Liver Failure
Safety and Clinical Activity of QEL-001 in A2-mismatch Liver Transplant Patients
The purpose of this study is to evaluate the safety and tolerability of QEL-001 in the prevention of liver transplant rejection following immunosuppression withdrawal.
- Conditions
- Rejection; Transplant, Liver, Liver Failure, Liver Diseases
- Trial name
- LIBERATE (NCT05234190)
- Testing
- QEL-001
- Where
- 10 sites in Belgium, Spain and 1 more
- Volunteers
- 33 people
- Sponsor
- Quell Therapeutics Limited
Kidney Transplantation
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor…
- Trial name
- RETIRE (NCT06552169)
- Testing
- Arm 1: SOC (mTOR + CNI), Arm 2A: TRACT/MONO mTOR, Arm 2B: TRACT/MONO CNI
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 34 people
- Sponsor
- Singulera Therapeutics Inc.
Heart Transplant Failure and Rejection
Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation
The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first…
- Trial name
- DETECT (NCT05081739)
- Testing
- Prospera Transplant Assessment, Endomyocardial biopsy
- Sponsor
- Natera, Inc.
Kidney Transplantation
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
- Trial name
- FREEDOM-2 (NCT01649388)
- Testing
- FCR001
- Where
- 3 sites in United States
- Sponsor
- Talaris Therapeutics Inc.
Infection in Solid Organ Transplant Recipients
T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays
The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)].
- Trial name
- PROTECT (NCT02382211)
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 600 people
- Sponsor
- Oxford Immunotec
Kidney Transplant Failure and Rejection
BIOtechnology Applied to Renal TRansplantation With IMmunobiogram
Immunobiogram (IMBG) is a novel in vitro diagnostic bioassay developed by Biohope Scientific Solutions for Human Health SL, that allows to measure the pharmacodynamic response to individual immunosuppressive drugs in patients…
- Trial name
- BIOTRAIM (NCT05816486)
- Testing
- Immunobiogram
- Where
- 15 sites in Brazil, France and 3 more
- Volunteers
- 443 people
- Sponsor
- Biohope Scientific Solutions for Human Health, S.L.
Age-Related Macular Degeneration
Study to Evaluate Sub-retinal Transplantation of Retinal Pigmented Epithelial Cells in Patients With Dry AMD
To evaluate the safety of 3 regimens of short-term, low-dose systemic IMT as rejection prophylaxis prior to and/or following transplant of MA09-hRPE cells.
- Trial name
- PORTRAY (NCT02563782)
- Testing
- Sub-retinal transplantation of MA09-hRPE cells, tacrolimus and mycophenolate mofetil
- Where
- United States
- Sponsor
- Astellas Institute for Regenerative Medicine