Who is sponsoring RTB-006?

RTB-006 is sponsored by Angus W. Thomson PhD DSc.

What condition does RTB-006 study?

RTB-006 studies Kidney Transplant, Renal Transplant Recipients.

What drugs are being tested in RTB-006?

Interventions: DCreg: 0.5 million cells/kg+SOC, DCreg: 1.2 million cells/kg+SOC, DCreg:2.5 to 5.0 million cells/kg+SOC.

What is the status of RTB-006?

RTB-006 is currently ACTIVE_NOT_RECRUITING.

Last reviewed 2026-04-30 · How we verify

Allogeneic Regulatory Dendritic Cell (DCreg) Therapy in Live-Donor Renal Transplant Recipients (RTB-006)

NCT03726307 Phase 1 ACTIVE_NOT_RECRUITING

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. 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.

Details

Lead sponsor	Angus W. Thomson PhD DSc
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	28
Start date	2019-04-10
Completion	2028-05

Conditions

Kidney Transplant
Renal Transplant Recipients

Interventions

DCreg: 0.5 million cells/kg+SOC
DCreg: 1.2 million cells/kg+SOC
DCreg:2.5 to 5.0 million cells/kg+SOC

Primary outcomes

Composite Outcome: Proportion of Participants who Experience any of the Pre-Specified Safety Events — 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).

Countries

United States