Kidney TransplantPhase 1RTB-006NCT03726307

Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study

A Phase 1 study testing DCreg: 0.5 million cells/kg+SOC, DCreg: 1.2 million cells/kg+SOC and DCreg:2.5 to 5.0 million cells/kg+SOC in people with Kidney Transplant and Renal Transplant Recipients, run by Angus W. Thomson PhD DSc at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study will evaluate the safety and feasibility of treatment involving a single infusion of donor-derived regulatory dendritic cells (DCreg) in first time, living donor renal transplant recipients. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Kidney Transplant, Renal Transplant Recipients
What is being tested?: DCreg: 0.5 million cells/kg+SOC, DCreg: 1.2 million cells/kg+SOC and DCreg:2.5 to 5.0 million cells/kg+SOC
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 10 Apr 2019to May 2028
Phase: Phase 1
Are there results?: Not yet: the study is under way

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Donor Eligibility Criteria:
Able to understand and provide informed consent;
Male or female >/= 18 years of age
Meets all standard institutional criteria for kidney donation and Health Agency criteria for kidney donation;
For females of childbearing potential, a negative urine or serum pregnancy test;
Negative for Human Immunodeficiency Virus type 1 (HIV) -1 (antigen and Nucleic Acid Testing (NAT)), HIV-2, Human T-cell leukemia virus type 1 (HTLV-1), and HTLV-2;

Show all 41Show fewer

Negative for hepatitis C (antibody and NAT), hepatitis B (surface antigen and core antibody), and Treponema pallidum infection;
Negative for West Nile Virus;
Negative health history for Creutzfeldt-Jakob disease;
No live vaccines within 8 weeks prior to leukapheresis;
No medical condition(s) that the investigator deems incompatible with participation in the trial; and
No use of investigational drugs within 12 weeks of participation.
Recipient Inclusion Criteria:
Must be able to understand and provide informed consent;
Is >/= 18 years old at the time of informed consent;
Is undergoing a living donor renal transplant;
For females of childbearing potential, a negative urine or serum pregnancy test upon study entry
The candidate agrees to use contraception with a method that is more than 80% effective (see FDA Office of Women's Health (http://www.fda.gov/birthcontrol). Female participants of child-bearing potential must consult with their physician and determine the most suitable method(s) to be used from one month before study treatment begins until one month after study completion;
Cytomegalovirus (CMV) seropositive or, if CMV seronegative must be receiving a kidney from a CMV seronegative donor;
Has a negative purified protein derivative (PPD) or negative testing for tuberculosis using an approved IGRA blood test, such as QuantiFERON®-Gold TB or T-SPOT-TB assay OR has completed treatment for latent tuberculosis and has a negative chest x-ray. PPD or IGRA testing must occur within 52 weeks before transplant. These requirements apply as well to prior recipients of Bacille Calmette-Guérin (BCG) vaccination;
Meets all standard institutional and Health Agency criteria for kidney transplant.
Vaccines up to date as per DAIT guidance for patients in transplant trials (Refer to Manual of Operations).
Study Exclusion Criteria:
Panel Reactive Antibody (PRA >20%);
Positive T or B Cell Flow Crossmatch prior to transplant;
Presence of donor specific antibody (DSA) ≥ to mean fluorescence intensity (MFI) of 1000, or DSA between 500 and 1000, if a specific shared epitope pattern is present;
Recipient of multi-organ transplant;
Any prior renal or extra-renal transplant with HLA class II antigen mismatch shared with prior organ;
Epstein-Barr Virus (EBV) Immunoglobulin G (IgG) negative if the donor is EBV positive;
Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (HCV) antibody (if hepatitis C antibody positive, confirm negative infection by HCV RNA), or positivity for hepatitis B surface antigen;
History of malignancy witin the past 5 years unless standard institutional criteria detailed in Appendix 6 have been met;
High risk for recurrence of renal disease: Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura (HUS-TTP); Focal Segmental Glomerular Sclerosis (FSGS); or Aggressive native kidney disease.
Compensated and decompensated cirrhosis of liver and/or portal hypertension;
Chronic Obstructive Pulmonary Disease requiring nasal oxygen, and/or pulmonary hypertension (mean pulmonary pressure >45mm/hg);
Any history of stroke with neurological deficit;
Any condition that, in the opinion of the investigator, confers excessive risk for participation in this phase 1 study;
Presence of a condition that requires treatment with an immunosuppressive agent, other than a physiologic dose of corticosteroid;
Live vaccines within 8 weeks prior to transplant;
Use of investigational drugs within 12 weeks of participation;
Woman receiving a kidney from a man who has fathered her child(ren), whether or not carried to term; or
Woman receiving a kidney from her biological child.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh, Starzl Transplantation Institute
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Allogeneic Regulatory Dendritic Cell (DCreg) Therapy in Live-Donor Renal Transplant Recipients

DCreg will be prepared from monocytes obtained by leukapheresis from prospective (non-mobilized) living kidney donors and infused into the respective recipients 7 days before renal transplantation. This study will enroll 28 subjects (14 recipients, 14 donors). The duration of follow-up will be:

1 week following the leukapheresis procedure for donors and
2 years following their DCreg infusion for kidney recipients.

Read the detailed description

This clinical trial is a single-center, open-label, dose-escalation, phase 1 study, enrolling N=14 de novo kidney transplant recipients and their respective living donors. The study objective is to evaluate the safety and feasibility of a single infusion of donor-derived regulatory dendritic cell (DCreg) treatment.

Transplant recipients will receive combination immunosuppressive agents according to the site's Standard of Care (SOC) regimen, with two exceptions:

mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
the pre-transplant dose of MPA will be half the standard post-transplant dose, due to increased drug bioavailability in recipients with low kidney function defined by glomerular filtration rate (GFR).

Consequently, participants will be maintained on triple immunosuppressive therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.

Note: Participants will not be withdrawn from known effective therapy for the purpose of participating in this research.

Conditions: Kidney Transplant, Renal Transplant Recipients
Being tested: DCreg: 0.5 million cells/kg+SOC, DCreg: 1.2 million cells/kg+SOC, DCreg:2.5 to 5.0 million cells/kg+SOC
Keywords: donor recipient pairs, allogeneic regulatory dendritic cell therapy (DCreg), DCreg therapy, de novo (first) live-donor renal transplant recipients

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DCreg: 0.5 million cells/kg+SOCBiological
Also called Regulatory Donor-Derived Dendritic Cells (DCreg)
DCreg 0.5 (±0.1) million cells/kilogram body weight infused as a single dose.
Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
- mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
- the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
DCreg: 1.2 million cells/kg+SOCBiological
Also called Regulatory Donor-Derived Dendritic Cells (DCreg)
DCreg 1.2 (±02) million cells/kilogram body weight infused as a single dose.
Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
- mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
- the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
DCreg:2.5 to 5.0 million cells/kg+SOCBiological
Also called Regulatory Donor-Derived Dendritic Cells (DCreg)
DCreg 2.5 to 5.0 million cells/kilogram body weight infused as a single dose.
Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
- mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
- the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.

Study groups in NCT03726307
Study group	Role	What they receive
DCreg: 0.5 million cells/kg+SOC	Experimental	N=3 participants will receive 0.5 (± 0.1) million cells/kg body weight as a single infusion. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide. Receives: Biological: DCreg: 0.5 million cells/kg+SOC
DCreg: 1.2 million cells/kg+SOC	Experimental	N=3 participants will receive 1.2 (± 0.2) million cells/kg body weight as a single infusion. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide. Receives: Biological: DCreg: 1.2 million cells/kg+SOC
DCreg:2.5 to 5.0 million cells/kg+SOC	Experimental	N=8 participants will receive 25 to 5.0 million cells /kg body weight as a single infusion. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide. Receives: Biological: DCreg:2.5 to 5.0 million cells/kg+SOC

What is being measured

The primary outcome is the main question the study is designed to answer.

Composite Outcome: Proportion of Participants who Experience any of the Pre-Specified Safety Events
Safety will be assessed by summarizing the proportion of participants who experience any of the following events from the initiation of the regulatory dendritic cells (DCreg) infusion administered 7 days prior to kidney transplant to 1 year post-transplant:
- Recipient death attributed to receipt of DCreg,
- NCI-CTCAE Grade 4 or higher DCreg infusion reaction,
- NCI-CTCAE Grade 4 or higher infection,
- Malignancy other than non-melanoma skin cancer,
- Pre-transplant Donor Specific Antibodies (DSA),
- Post-transplant DSA,
- Biopsy-proven acute rejection (BPAR) by BANFF 2017 criteria (grade ≥2A), or
- Non-surgical graft loss.
- Reference: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0).
Measured: Seven Days Prior to Transplant Surgery(e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant

Secondary outcomes (8)

Incidence of Death Attributed to Participant Receipt of Regulatory Dendritic Cells (DCreg)
The occurrence of death among participants who receive DCreg treatment.
Measured: Seven Days Prior to Transplant Surgery (e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Incidence of Adverse Event: CTCAE Grade 4 or Higher Infusion Reaction
The number of Grade 4 or higher infusion reaction(s) among participants who receive regulatory dendritic cells (DCreg) infusion, graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0).
Measured: Seven Days Prior to Transplant Surgery (e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Incidence of Adverse Event:CTCAE Grade 4 or Higher Infection
The number of Grade 4 or higher infection(s) among participants who receive regulatory dendritic cells (DCreg) infusion, graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0).
Measured: Seven Days Prior to Transplant Surgery (e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Incidence of Adverse Event: Malignancy
The number of malignancies among participants who receive regulatory dendritic cells (DCreg) infusion. Not included in this incidence outcome: non-melanoma skin cancer(s).
Measured: Seven Days Prior to Transplant Surgery(e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Incidence of Pre-Transplant Donor Specific Antibodies (DSA)
The number of pre-transplant DSA among participants occurring after DCreg infusion and before transplant.
Measured: Baseline (Seven Days Prior to Transplant Surgery, "Pre" -Regulatory Dendritic Cells (DCreg)) Infusion) up to within 48 Hours of Transplant
Incidence of Post-Transplant Donor Specific Antibodies (DSA)
A de novo DSA occurring within the first year post-transplant.
Measured: Day 0 (Transplant Surgery) up to 1-Year Post-Transplant
Incidence of Biopsy-Proven Acute Rejection
Acute kidney allograft rejection is defined by a kidney (renal) allograft biopsy classification of grade 2A or higher. Classification method: Banff 2013. The Banff 2013 classification for antibody-mediated rejection is a recognized standard in renal allograft pathology.
Measured: Day 0 (Transplant Surgery) up to 1-Year Post-Transplant
Incidence of Non-Surgical Graft Loss
Graft loss not associated with the transplant surgery.
Measured: Day 0 (Transplant Surgery) up to 1-Year Post-Transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 2019May 2028

First posted31 Oct 2018
Study start10 Apr 2019
Primary completionMay 2027 (estimated)
Study completionMay 2028 (estimated)

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 TransplantStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Open-label, dose-escalation, phase 1 clinical trial.
Masking: None (open label)
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03726307
Sponsor's protocol ID: STUDY19040393
Other IDs: U01AI136779
Acronym: RTB-006
Status last verified: Apr 2026
First submitted: 29 Oct 2018
Last updated: 5 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Haas M, Sis B, Racusen LC, Solez K, Glotz D, Colvin RB, Castro MC, David DS, David-Neto E, Bagnasco SM, Cendales LC, Cornell LD, Demetris AJ, Drachenberg CB, Farver CF, Farris AB 3rd, Gibson IW, Kraus E, Liapis H, Loupy A, Nickeleit V, Randhawa P, Rodriguez ER, Rush D, Smith RN, Tan CD, Wallace WD, Mengel M; Banff meeting report writing committee. Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions. Am J Transplant. 2014 Feb;14(2):272-83. doi: 10.1111/ajt.12590.
PubMed 24472190
Haas M. The Revised (2013) Banff Classification for Antibody-Mediated Rejection of Renal Allografts: Update, Difficulties, and Future Considerations. Am J Transplant. 2016 May;16(5):1352-7. doi: 10.1111/ajt.13661. Epub 2016 Feb 4.
PubMed 26696524

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Allogeneic Regulatory Dendritic Cell (DCreg) Therapy in Live-Donor Renal Transplant Recipients
ClinicalTrials.gov ID: NCT03726307
Acronym / sponsor ID: RTB-006 / STUDY19040393
Conditions: Kidney Transplant, Renal Transplant Recipients
Keywords: donor recipient pairs, allogeneic regulatory dendritic cell therapy (DCreg), DCreg therapy, de novo (first) live-donor renal transplant recipients
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 28 participants (estimated)
Lead sponsor: Angus W. Thomson PhD DScUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 10 Apr 2019 (actual)
Primary completion: May 2027 (estimated)
Study completion: May 2028 (estimated)
First posted: 31 Oct 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.

1 week following the leukapheresis procedure for donors and
2 years following their DCreg infusion for kidney recipients.

Detailed description

Transplant recipients will receive combination immunosuppressive agents according to the site's Standard of Care (SOC) regimen, with two exceptions:

mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
the pre-transplant dose of MPA will be half the standard post-transplant dose, due to increased drug bioavailability in recipients with low kidney function defined by glomerular filtration rate (GFR).

Note: Participants will not be withdrawn from known effective therapy for the purpose of participating in this research.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Open-label, dose-escalation, phase 1 clinical trial.

Arm	Type	Receives
DCreg: 0.5 million cells/kg+SOC	Experimental	Biological: DCreg: 0.5 million cells/kg+SOCN=3 participants will receive 0.5 (± 0.1) million cells/kg body weight as a single infusion. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
DCreg: 1.2 million cells/kg+SOC	Experimental	Biological: DCreg: 1.2 million cells/kg+SOCN=3 participants will receive 1.2 (± 0.2) million cells/kg body weight as a single infusion. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.
DCreg:2.5 to 5.0 million cells/kg+SOC	Experimental	Biological: DCreg:2.5 to 5.0 million cells/kg+SOCN=8 participants will receive 25 to 5.0 million cells /kg body weight as a single infusion. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (41 listed)

Able to understand and provide informed consent;
Male or female >/= 18 years of age
Meets all standard institutional criteria for kidney donation and Health Agency criteria for kidney donation;
For females of childbearing potential, a negative urine or serum pregnancy test;
Negative for Human Immunodeficiency Virus type 1 (HIV) -1 (antigen and Nucleic Acid Testing (NAT)), HIV-2, Human T-cell leukemia virus type 1 (HTLV-1), and HTLV-2;

Key exclusion criteria (0 listed)

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
DCreg: 0.5 million cells/kg+SOCAlso: Regulatory Donor-Derived Dendritic Cells (DCreg)DCreg 0.5 (±0.1) million cells/kilogram body weight infused as a single dose. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.	Biological	DCreg: 0.5 million cells/kg+SOC
DCreg: 1.2 million cells/kg+SOCAlso: Regulatory Donor-Derived Dendritic Cells (DCreg)DCreg 1.2 (±02) million cells/kilogram body weight infused as a single dose. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.	Biological	DCreg: 1.2 million cells/kg+SOC
DCreg:2.5 to 5.0 million cells/kg+SOCAlso: Regulatory Donor-Derived Dendritic Cells (DCreg)DCreg 2.5 to 5.0 million cells/kilogram body weight infused as a single dose. Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions: * mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and * the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR). Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide.	Biological	DCreg:2.5 to 5.0 million cells/kg+SOC

Primary outcome

Composite Outcome: Proportion of Participants who Experience any of the Pre-Specified Safety Events
Time frame: Seven Days Prior to Transplant Surgery(e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Safety will be assessed by summarizing the proportion of participants who experience any of the following events from the initiation of the regulatory dendritic cells (DCreg) infusion administered 7 days prior to kidney transplant to 1 year post-transplant: * Recipient death attributed to receipt of DCreg, * NCI-CTCAE Grade 4 or higher DCreg infusion reaction, * NCI-CTCAE Grade 4 or higher infection, * Malignancy other than non-melanoma skin cancer, * Pre-transplant Donor Specific Antibodies (DSA), * Post-transplant DSA, * Biopsy-proven acute rejection (BPAR) by BANFF 2017 criteria (grade ≥2A), or * Non-surgical graft loss. * Reference: National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.0).

8 secondary outcomes

Incidence of Death Attributed to Participant Receipt of Regulatory Dendritic Cells (DCreg)
Time frame: Seven Days Prior to Transplant Surgery (e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Incidence of Adverse Event: CTCAE Grade 4 or Higher Infusion Reaction
Time frame: Seven Days Prior to Transplant Surgery (e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Incidence of Adverse Event:CTCAE Grade 4 or Higher Infection
Time frame: Seven Days Prior to Transplant Surgery (e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Incidence of Adverse Event: Malignancy
Time frame: Seven Days Prior to Transplant Surgery(e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant
Incidence of Pre-Transplant Donor Specific Antibodies (DSA)
Time frame: Baseline (Seven Days Prior to Transplant Surgery, "Pre" -Regulatory Dendritic Cells (DCreg)) Infusion) up to within 48 Hours of Transplant
Incidence of Post-Transplant Donor Specific Antibodies (DSA)
Time frame: Day 0 (Transplant Surgery) up to 1-Year Post-Transplant
Incidence of Biopsy-Proven Acute Rejection
Time frame: Day 0 (Transplant Surgery) up to 1-Year Post-Transplant
Incidence of Non-Surgical Graft Loss
Time frame: Day 0 (Transplant Surgery) up to 1-Year Post-Transplant

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Background: PubMed 24472190Haas M, Sis B, Racusen LC, Solez K, Glotz D, Colvin RB, Castro MC, David DS, David-Neto E, Bagnasco SM, Cendales LC, Cornell LD, Demetris AJ, Drachenberg CB, Farver CF, Farris AB 3rd, Gibson IW, Kraus E, Liapis H, Loupy A, Nickeleit V, Randhawa P, Rodriguez ER, Rush D, Smith RN, Tan CD, Wallace WD, Mengel M; Banff meeting report writing committee. Banff 2013 meeting report: inclusion of c4d-negative antibody-mediated rejection and antibody-associated arterial lesions. Am J Transplant. 2014 Feb;14(2):272-83. doi: 10.1111/ajt.12590.
Background: PubMed 26696524Haas M. The Revised (2013) Banff Classification for Antibody-Mediated Rejection of Renal Allografts: Update, Difficulties, and Future Considerations. Am J Transplant. 2016 May;16(5):1352-7. doi: 10.1111/ajt.13661. Epub 2016 Feb 4.
NIH NCI Common Terminology Criteria for Adverse Events (CTCAE)Link provided by the sponsor.

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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.

Amit D. Tevar, MD, FACS study chair

University of Pittsburgh: Starzl Transplantation Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 41 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Composite Outcome: Proportion of Participants who Experience any of the Pre-Specified Safety Events (time frame: Seven Days Prior to Transplant Surgery(e.g. Day of Regulatory Dendritic Cells (DCreg) Infusion) up to 1-Year Post-Transplant). 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 NCT03726307, 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 5 May 2026.