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CD19-specific CAR-T Cells in CLL / SLL and DLBCL

Trial Status: Active

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 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).

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

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Elaine Hoekstra
Phone: 773-834-8980

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: William Wesson
Phone: 913-588-6029

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Novartis Pharmaceuticals Corporation

  • Primary ID CYTB323A12101
  • Secondary IDs NCI-2020-08168
  • Clinicaltrials.gov ID NCT03960840