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Graft vs Host Disease clinical trials

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NCT ID: NCT05993611 Recruiting - Clinical trials for Chronic Graft Versus Host Disease

Allogeneic CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) for the Treatment of Patients With Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation

Start date: June 17, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of allogeneic CD6 chimeric antigen receptor T regulatory cells (CD6-CAR Tregs) in treating patients who have chronic graft versus host disease (cGVHD) after an allogeneic hematopoietic cell transplantation (HCT). An allogeneic HCT is an established treatment for benign or malignant blood and marrow conditions where healthy stem cells from a donor are infused into a patient to help the patient's bone marrow make more healthy cells and platelets. GVHD is a systemic disorder that occurs when the graft's immune cells recognize the host as foreign and attack the recipient's body cells. "Graft" refers to transplanted, or donated tissues, and "host" refers to the tissues of the recipient. It is a common complication after allogeneic HCT. The onset of cGVHD is usually within three years of transplantation and has some features of autoimmune diseases. A strategy that minimizes the incidence and severity of cGVHD, without other adverse effects, is needed to improve survival after allogeneic HCT. T regulatory cells are critical for controlling autoimmunity and maintaining immune homeostasis. Patients with active cGVHD have reduced numbers of T regulatory cells compared to patients without GVHD, suggesting that restoration of T regulatory cells in patients with active cGCHD is impaired and insufficient numbers may contribute to cGVHD. Therefore, therapies that augment numbers and function of T regulatory cells may promote tolerance and control of cGVHD. CAR T-cell therapy is a type of treatment in which T cells (a type of immune system cell) are taken from the blood and changed in the laboratory. The gene for a special receptor that binds to a certain protein, CD6, on the patient's cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion. CD6-CAR Tregs combines the CD6-targeted anti-inflammatory response with the immune regulatory properties of T regulatory cells which could generate a more potent and stable T regulatory cell population to promote immune tolerance and long-term disease control in cGVHD.

NCT ID: NCT05969743 Not yet recruiting - Clinical trials for Graft-versus-host-disease

Letermovir Prophylaxis for Cytomegalovirus (CMV) in Patients With Graft-versus-host Disease

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

Explore the tolerability and efficacy of letermovir in the prevention of CMV reactivation in patients with acute and chronic graft-versus-host disease (GVHD) beyond day 100.

NCT ID: NCT05968170 Not yet recruiting - Clinical trials for Acute Myeloid Leukemia

TCRαβ/CD19 Depletion of Stem Cell Grafts for Transplant

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The CliniMACS® device is FDA-approved only for one indication (CD34+ selection). Additional use of this device outside of this indication requires the use of feasibility studies. Children, adolescents and young adults with malignant and non-malignant conditions undergoing hematopoietic stem cell transplants will have stem cells selected using alpha-beta+/CD19+ cell depletion. This is a single arm feasibility study using this processing of peripheral stem cells with alternative donor sources (haploidentical, mismatched, matched unrelated) to determine efficacy as seen by engraftment and graft-versus-host disease (GVHD).

NCT ID: NCT05922761 Recruiting - Lung Diseases Clinical Trials

BElumosudil for Bronchiolitis Obliterans Prevention/Therapy (BEBOP)

Start date: January 2, 2024
Phase: Phase 2
Study type: Interventional

The goal of this research study is to test the efficacy of a novel immunosuppressive agent, belumosudil, in allogeneic hematopoietic stem cell transplant (HSCT) recipients who have been newly diagnosed or have developing (early stage) bronchiolitis obliterans syndrome (BOS). The name of the study drugs involved in this study are: - Belumosudil (an immunotherapy) - Fluticasone (an intranasal corticosteroid) - Azithromycin (an antibiotic) - Montelukast (a leukotriene receptor antagonist) - Prednisone (a corticosteroid)

NCT ID: NCT05921305 Recruiting - Clinical trials for Acute Graft Versus Host Disease

Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

Start date: August 3, 2023
Phase: Phase 3
Study type: Interventional

This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.

NCT ID: NCT05919511 Recruiting - cGVHD Clinical Trials

Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease

THRIVE
Start date: August 2, 2023
Phase:
Study type: Observational

The purpose of this prospective observational study is to collect data from participants who have recently had an allogenic Stem Cell Transplant(alloSCT) and are at risk of Chronic Graft Versus Host Disease(cGVHD)

NCT ID: NCT05885451 Completed - Clinical trials for Chronic Graft-versus-Host Disease (cGVHD)

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of AMG 592 in Healthy Japanese Participants

Start date: January 29, 2019
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.

NCT ID: NCT05873907 Completed - Clinical trials for Chronic Graft-versus-host Disease (cGVHD)

A Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of AMG 592 in Healthy Participants

Start date: October 19, 2015
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of AMG 592 in healthy participants.

NCT ID: NCT05866302 Recruiting - Clinical trials for Graft Versus Host Disease

Parametric Response Mapping (PRM) for the Detection of Chronic Lung Injury in Hematopoietic Cell Transplant Recipients

Start date: May 30, 2023
Phase:
Study type: Observational

The study will have two separate patient cohorts: Cohort 1 will include patients with newly diagnosed chronic graft versus host disease (GVHD), whereas cohort 2 will include patients with newly diagnosed chronic lung disease (CLD). For cohort 1, the primary objective will be to characterize PRM metrics at the onset of chronic GVHD and determine if a PRM signature is present that will predict 1-year CLD free survival. For cohort 2, the primary objective will focus on characterizing PRM at the onset of CLD and determine if PRM can predict the trajectory in lung function decline in affected patients.

NCT ID: NCT05856058 Completed - Clinical trials for Graft-versus-host Disease

To Assess SHR0302 Oral Solutions and Tablets in Healthy Subjects Clinical Studies of Relative Bioavailability

Start date: May 29, 2023
Phase: Phase 1
Study type: Interventional

To assess the relative bioavailability of SHR0302 oral solution and tablet in healthy subjects. To assess the safety and tolerability of a single dose of SHR0302 oral solution and tablet.