Spots Global Cancer Trial Database for CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies
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Trial Identification
Brief Title: CD22-CAR T Cells in Children and Young Adults With B Cell Malignancies
Official Title: Phase Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies
Study ID: NCT04088864
Study Description
Brief Summary: The primary purpose of this study is to test whether CD22-CAR T cells can be successfully made from immune cells collected from pediatric and young adult subjects with relapsed/refractory B-cell malignancies (leukemia and lymphoma). Another purpose of this study is to test the safety and cancer killing ability of a cell therapy against a new cancer target (CD22).
Detailed Description: PRIMARY OBJECTIVE: * Determine the feasibility of manufacturing CD22 CAR T cells for administration to children and young adults with relapsed/refractory (R/R) CD22 expressing B-cell ALL or lymphoma using the Miltenyi CliniMACS Prodigy system. * Determine the safety of an established dose of CD22-CAR T cells in children and young adults with R/R CD22 expressing B-cell malignancies. SECONDARY OBJECTIVE: - Assess the clinical activity of CD22-CAR T cells in children and young adults with R/R CD22 expressing B-cell malignancies, including overall survival (OS) and progression free survival (PFS).
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Stanford Medical Center, Stanford, California, United States
Contact Details
Name: Liora Schultz, MD
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR
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