Clinical Study of Chimeric CD(Cluster of Differentiation)19 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory B-cell Leukemias and Lymphomas
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
with the anti-CD19 (cluster of differentiation antigen 19 ) vector (referred to as CART-19
II. Determine duration of in vivo survival of CART-19 cells. RT-PCR (reverse transcription
polymerase chain reaction) analysis of whole blood will be used to detect and quantify
survival of CART-19 TCR (T-cell receptor) zeta:CD137 and TCR zeta cells over time.
I. For patients with detectable disease, measure anti-tumor response due to CART-19 cell
II. To determine if the CD137 transgene is superior to the TCR zeta only transgene as
measured by the relative engraftment levels of CART-19 TCR zeta:CD137 and TCR zeta cells
III. Estimate relative trafficking of CART-19 cells to tumor in bone marrow and lymph nodes.
IV. For patients with stored or accessible tumor cells (such as patients with active chronic
lymphocytic leukemia(CLL), acute lymphocytic leukemia (ALL), etc) determine tumor cell
killing by CART-19 cells in vitro.
V. Determine if cellular or humoral host immunity develops against the murine anti-CD19, and
assess correlation with loss of detectable CART-19 (loss of engraftment).
VI. Determine the relative subsets of CART-19 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-CD19-CAR (coupled with CD137 and CD3 zeta signalling
domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3
months for 2 years, and annually thereafter for 13 years.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Occurrence of study related adverse events
defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment
Until week 24
China: Ethics Committee