Table 2 Ongoing clinical trials of Treg cells and/or therapeutic agents are being conducted for human diseases. (Selected examples)
From: Regulatory T cells in homeostasis and disease: molecular mechanisms and therapeutic potential
Intervention/Treatment | Disease types | Purpose | Identifier | Trial phase |
|---|---|---|---|---|
Umbilical Cord Blood (UCB)-Treg + Liraglutide | Autoimmune Diabetes | The purpose of this study is to examine the safety as well as the therapeutic effect of ex-vivo expanded umbilical cord blood regulatory T cells when used in combination with Liraglutide in the treatment of autoimmune diabetes | NCT03011021 | I/II |
CD4^LVFOXP3 | Immune dysregulation, Poly endocrinopathy, Enteropathy, X-linked (IPEX) | To test the feasibility of manufacturing and the safety of administering CD4^LVFOXP3 in up to 30 evaluable human participants with IPEX, and to evaluate the impact of CD4^LVFOXP3 infusion on the disease | NCT05241444 | I |
UCB-Treg | Autoimmune Diabetes | The purpose of this study is to examine the safety and the therapeutic effect of regulatory T cells from ex-vivo expanded umbilical cord blood in the treatment of autoimmune diabetes | NCT02932826 | I/II |
Infusion of autologous human polyclonal Treg cell | Amyotrophic lateral sclerosis, Multiple System Atrophy (MSA), Alzheimer’s Disease | To evaluate the safety and efficacy of injecting autologous human polyclonal regulatory T cells (NP001 cell injection) in patients with neurodegenerative diseases such as ALS, MSA, and AD | NCT06671236 | I |
RAPA-501 autologous T cells | Amyotrophic Lateral Sclerosis | The purpose of the RAPA-501-ALS study is to conduct a phase 2/3 expansion cohort study to evaluate the RAPA-501 autologous hybrid TREG/Th2 cells in patients with amyotrophic lateral sclerosis (pwALS) | NCT04220190 | II/III |
Infusion of TRK-001 | Kidney transplantation | To determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients | NCT06552169 | II |
Infusion of Treg cell | Heart transplantation | To develop a protocol for isolating Treg cells (thyTreg) from discarded thymic tissue in pediatric cardiac surgeries and then conduct a phase I/II clinical trial after pre-clinical studies to test the safety and efficacy of adoptively transferring autologous thyTreg for preventing rejection in children undergoing heart transplants | NCT04924491 | I/II |
Infusion of recipient Treg cell | Islet transplantation | The purpose of this clinical trial is to evaluate whether patients with brittle type 1 diabetes can achieve better blood sugar control after islet transplantation when receiving one of two types of immune cells (either their own regulatory T cells or immune cells from the islet donor’s bone marrow) along with the islet transplant. It also aims to assess the feasibility and safety of combining an islet transplant with the recipient’s Tregs or deceased donor bone marrow cells in these patients | NCT05973734 | I |
Infusion of Treg cell | Advanced Hematologic Cancer | Studying the side effects and best dose of donor Treg cells after an umbilical cord blood transplant in treating patients with advanced hematologic cancer or other disorder | NCT00602693 | I |
DLI-Boost | Hematological Malignancies | Show the advantage of Treg-depleted donor lymphocyte infusion (DLI) over standard DLI for treating relapse in blood cancers after HSCT | NCT03236129 | III |
Infusion of Treg cell | Relapsed/refractory and Ultra-high-risk AML and/or MDS | Whether the IS-free Treg-cell graft-engineered haplo HSCT approach will reduce risk of relapse while preventing usual toxicities related to stem cell transplants | NCT04678401 | I |
ILDTreg2 | Hematological Malignancies | To enhance anti-tumor immune responses by selectively depleting Treg using CD127 as a marker in the context of DLI for relapsing hematological malignancies after allogeneic HSCT | NCT06180499 | I/II |
Infusion of depleted Treg cell | Relapsed Hematologic Malignancies | Evaluate the safety and efficacy of CD25+Treg depletion in DLI products using CliniMACS for optimal dosing in post-transplant relapsed hematologic malignancy patients | NCT00675831 | I |
Infusion of Treg cell | Myeloid Leukemia, Lymphoma, MDS | Assess the efficacy, safety, and feasibility of various Tcon and Treg dose combinations in HCT patients with HLA-matched donors using T cell-depleted grafts | NCT01660607 | I/II |
High dose irradiation conditioning + Treg/Tcon | Acute Myeloid Leukemia Acute Lymphoid Leukemia | Determine if hyper-fractionated TBI or TMLI combined with Treg/Tcon immunotherapy enhances cGvHD/disease-free survival post-HSCT in high-risk acute leukemia or other hematologic malignancy patients | NCT03977103 | II |
Infusion of Treg cell | Hematologic Malignancies | Estimate the rate of grade II-IV acute GVHD after infusing tTreg cells at a fixed ratio to the total CD3+ cell count from two UCB grafts in double UCB transplant recipients | NCT02118311 | II |
Infusion of Treg cell | aGVHD after UCB HSCT for Heme Malignancies | Adoptive transfer of T regulatory cell for suppression of acute graft-vs-host-disease after an umbilical cord blood transplant for hematologic malignancies | NCT02991898 | II |
Selectively depleting Treg cell | Advanced Metastatic Colorectal Cancer | Controlled and selective depletion of regulatory T-cell for cancer treatment, efficacy and safety study | NCT00986518 | I/II |
Infusion of Treg cell | Hematologic Malignancies | Determine the optimal doses of UCB Treg and CD3+ Teff cells to be infused, with the objective of maximizing the number of CD3+ Teff cells while avoiding grade II-IV acute GVHD | NCT01163201 | I/II |
Infusion of Treg cell | High-Risk Leukemia or other Hematologic Diseases | To evaluate the safety and determine the optimal dose of umbilical cord blood T-regulatory cell infusion followed by donor umbilical cord blood transplant in patients with high-risk leukemia or other hematologic diseases | NCT00376519 | I |
CAR19-tTreg | Lymphoma Leukemia | To evaluate the safety and potential effectiveness of allogeneic CAR19-tTreg in adults with relapsed/refractory (R/R) CD19+ B Acute Lymphocytic Leukemia (B-ALL), specifically to manage immune-related side effects from CD19-targeted therapies like CAR T-cell therapy, by modulating immune responses that may cause cytokine release syndrome or other toxicities | NCT05114837 | I/II |
Recombinant WT1ASCI+ Infusion of Treg depleted T Cells | Adult WT1 Acute Myeloid Leukemia | To evaluate the safety and the efficacy of combined treatment strategy of WT1ASCI, infusion of ex vivo regulatory T cells depleted T lymphocytes and in vivo regulatory T cells depletion as post-consolidation therapy in patients with WT1-positive Acute Myeloid Leukemia | NCT01513109 | I |
Infusion of Treg cell | Hematologic Malignancies | A feasibility trial of post-transplant Infusion of allogeneic regulatory t cells and allogeneic conventional T cells in patients with hematologic malignancies undergoing allogeneic myeloablative hematopoietic cell transplantation from haploidentical-related donors | NCT01050764 | I/II |
CD19/CD22-CAR-T | Adults With B-cell Acute Lymphoblastic Leukemia | To assess the safety of administering allogenic, donor-derived CD19/CD22-CAR T cells that meet established release specifications in adults with B-cell ALL following a myeloablative conditioning regimen and Orca-T to determine if this will augment graft versus leukemia without increasing acute GVHD or graft failure | NCT05507827 | I |
Infusion of Treg cell | Hematologic Malignancies | Compare Orca-T (“Orca-T”, a T-cell-depleted graft with additional infusion of conventional T cells and regulatory T cells) to standard care in patients undergoing MA-alloHCT for blood cancers, focusing on safety and efficacy | NCT05316701 | III |
Infusion of Treg cell | Hematologic Malignancies | Assess the safety, tolerability, and effectiveness of Orca-T, an engineered donor graft with added T cells, in patients receiving allogeneic stem cell transplants for blood cancers | NCT04013685 | I |
