Pilot Study of Redirected Autologous T Cells Transduced to Express A CD20-Specific Chimeric Immunoreceptor in Patient With Chemotherapy Resistant or Refractory CD20+ Leukemia and Lymphoma
I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced
with the anti-CD20 vector (referred to as CART-20 cells).
II. Determine duration of in vivo survival of CART-20 cells. RT-PCR analysis of whole blood
will be used to detect and quantify survival of CART-20 TCR zeta:4-1BB and TCR zeta cells
I. For patients with detectable disease, measure anti-tumor response due to CART-20 cell
II. To determine if the 4-1BB transgene is superior to the TCR zeta only transgene as
measured by the relative engraftment levels of CART-20 TCR zeta:4-1BB and TCR zeta cells
III. Estimate relative trafficking of CART-20 cells to tumor in bone marrow and lymph nodes.
IV. For patients with stored or accessible tumor cells (such as patients with active CLL,
ALL, etc) determine tumor cell killing by CART-20 cells in vitro.
V. Determine if cellular or humoral host immunity develops against the murine anti-CD20, and
assess correlation with loss of detectable CART-20 (loss of engraftment).
VI. Determine the relative subsets of CART-20 T cells (Tcm, Tem, and Treg).
OUTLINE: Patients are assigned to 1 of 2 groups according to order of enrollment.
Group 1 (Patients 1-5): Patients receive anti-CD20-CAR vector-transduced autologous T cells
with 41BB-gamma vector on days 0,1, 2, and 11 in the absence of disease progression or
Group 2 (Patients 6-10): Patients receive anti-CD20-CAR vector-transduced autologous T cells
with either 41BB-gamma vector or TCR zeta vector on days 0,1, 2, and 11 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 of Chinese PLA General Hospital