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
A First-in-Human Study to Evaluate the Safety, Feasibility and Tolerability of Allogeneic CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) in Patients With Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Cell Transplantation (alloHCT)
Sponsor: City of Hope Medical Center + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Dose-limiting toxicity
Time frame: From infusion of Allogeneic CD6 chimeric antigen receptor T regulatory cells (CD6-CAR Tregs) to day +28
Feasibility as the ability to met at least 80% of the required cell dose at the assigned dose level
Time frame: From infusion of CD6-CAR Tregs to day +28
Feasibility as the ability to meet the required produce release criteria
Time frame: From infusion of CD6-CAR Tregs to day +28
Secondary Endpoints
CD6-CAR Treg activity
Changes in cGVHD severity
Failure-free survival (FFS)
Eligibility Criteria
Inclusion Criteria: * PATIENT (RECIPIENT) INCLUSION CRITERIA: * All participants must have the ability to understand and the willingness to sign a written informed consent * Participants must agree to allow the use of archival tissue from diagnostic biopsies. * If unavailable, exceptions may be granted with study PI approval Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated full consent is processed * Age \>= 18 years * Karnofsky performance status of \>= 70% * Received allogeneic hematopoietic stem cell transplantation (alloHCT) from matched related or haploidentical donor as part of treatment of hematologic disorders Note: The donor needs to consent for leukapheresis * Clinical diagnosis of steroid-dependent or refractory, moderate to severe cGVHD * Steroid refractory cGVHD defined as having persiste…
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