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

  • End date
    Oct 9, 2025
  • participants needed
  • sponsor
    Novartis Pharmaceuticals
Updated on 19 January 2022


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).

Condition Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; Diffuse Large B-cell Lymphoma; Acute Lymphoblastic Leukemia
Treatment YTB323 and ibrutinib, YTB323 single agent
Clinical Study IdentifierNCT03960840
SponsorNovartis Pharmaceuticals
Last Modified on19 January 2022


Yes No Not Sure

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
Clear my responses

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