Chronic Lymphocytic Leukemia Clinical Trial
CD19-specific CAR-T Cells in CLL/SLL, DLBCL and ALL
Summary
This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a CD19-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated in combination with ibrutinib in leukemia-cll/" >chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (DLBCL) and in adult acute lymphoblastic leukemia (ALL).
Eligibility Criteria
Inclusion Criteria:
ECOG performance status 0-1
CLL or SLL diagnosis according to iwCLL criteria
CLL/SLL in SD or PR after at least 6 months of ibrutinib, either as second or subsequent line of therapy
DLBCL diagnosis by local histopathology
DLBCL relapsed or refractory after 2 or more lines of therapy, including autologous hematopoietic stem cell transplantation (HSCT)
Refractory or relapsed CD19-positive ALL
ALL with morphologic disease in the bone marrow
Exclusion Criteria:
Prior CD19-directed therapy
Prior administration of a genetically engineered cellular product
Prior allogeneic HSCT
Richter's transformation
Active CNS lymphoma
Targeted small molecule or kinase inhibitor within 2 weeks from leukapheresis
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There are 30 Locations for this study
Stanford California, 94305, United States More Info
Principal Investigator
Tampa Florida, 33612, United States More Info
Principal Investigator
Atlanta Georgia, 30342, United States More Info
Principal Investigator
Chicago Illinois, 60611, United States More Info
Principal Investigator
Chicago Illinois, 60637, United States More Info
Principal Investigator
Westwood Kansas, 66205, United States More Info
Principal Investigator
Boston Massachusetts, 02114, United States More Info
Principal Investigator
Philadelphia Pennsylvania, 19104, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Houston Texas, 77030, United States More Info
Principal Investigator
Milwaukee Wisconsin, 53226, United States More Info
Principal Investigator
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
Wien , A-109, Austria
Marseille , 13273, France
Paris Cedex 10 , 75475, France
Pierre Benite Cedex , 69495, France
Frankfurt , 60590, Germany
Koeln , 50937, Germany
Bergamo BG, 24128, Italy
Bologna BO, 40138, Italy
Milano MI, 20132, Italy
Fukuoka city Fukuoka, 812-8, Japan
Sapporo city Hokkaido, 060 8, Japan
Bunkyo ku Tokyo, 113-8, Japan
Sevilla Andalucia, 41013, Spain
Barcelona Catalunya, 08035, Spain
Valencia Comunidad Valenciana, 46010, Spain
Barcelona , 08041, Spain
Madrid , 28009, Spain
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