Spots Global Cancer Trial Database for Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
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Trial Identification
Brief Title: Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
Official Title: Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial
Study ID: NCT03676504
Study Description
Brief Summary: Adult patients with r/r acute lymphoblastic leukemia (ALL) (stratum I), r/r Non-Hodgkin's lymphoma (NHL) including chronic lymphocytic leukaemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) or mantle cell lymphoma (MCL) (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by the third-generation RV-SFG.CD19.CD28.4-1BBzeta retroviral vector. The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (0,1-20×20\^7 transduced cells/m\^2) after lymphodepletion with fludarabine and cyclophosphamide.
Detailed Description:
Keywords
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital Heidelberg, Heidelberg, , Germany
University Hospital Heidelberg, Heidelberg, , Germany
Contact Details
Name: Prof. Dr. Michael Schmitt
Affiliation: University Hospital Heidelberg, Department V
Role: PRINCIPAL_INVESTIGATOR
Name: Prof. Dr. Andreas Kulozik
Affiliation: University Hospital Heidelberg, University Medical Center for Children and Adolescents
Role: PRINCIPAL_INVESTIGATOR
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