protocolSection identificationModule nctId: NCT06298019, orgStudyIdInfo id: 73464, briefTitle: Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2039-04, studyFirstPostDateStruct date: 2024-03-07, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Stanford University, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called "CD19" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these "re-engineered" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will "wipe out" all/most of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease.The main questions the study intends to answer are:* Understanding how well patients tolerate undergoing this therapy in terms of side effects;* Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs;, conditionsModule conditions: Dermatomyositis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: Patients will be enrolled in a sequential manner with respect to the aggressiveness of the conditioning regimen used prior to receiving the CAR T infusion therapy. The first 3 patients will undergo standard conditioning--daily cyclophosphamide (IV, 300 mg/m2) and fludarabine (30 mg/m2) x 3 days. If this regimen is found to allow sufficient engraftment of the CAR T cells, participants will be enrolled in sequential groups (of 3-5) representing milder doses or alternative medications that overall represent gentler cytoreduction, which advancement to each sequential group contingent upon satisfactory number and function of infused CAR T cells., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 21, type: ESTIMATED, armsInterventionsModule interventions name: KYV-101, outcomesModule primaryOutcomes measure: Number of participants experiencing adverse events, eligibilityModule sex: ALL, minimumAge: 25 Years, maximumAge: 72 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Stanford University, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, lon: -122.16608, hasResults: False