Table 1.
Patient demographics and response. CR, complete response; PR, partial response; N/A, not available.
Subject UPN | Age/sex karyotype | Previous therapies | CLL tumor burden at baseline
|
Total dose of CART19 (cells/kg) | Response day +30 (duration) | ||
---|---|---|---|---|---|---|---|
BM (study day)‡ | Blood (study day)‡ | Nodes/spleen (study day)‡ | |||||
01 | 65/M normal | Fludarabine × four cycles (2002) | Hypercellular 70% CLL | N/A | 6.2 × 1011 to 1.0 × 1012 CLL cells (day −37) | 1.1 × 109 (1.6 × 107/kg) | CR (11+ months) |
Rituximab/fludarabine × four cycles (2005) | 2.4 × 1012 CLL cells (day −14) | ||||||
Alemtuzumab × 12 weeks (2006) | 1.7 × 1012 CLL cells (day −1) | ||||||
Rituximab (two courses, 2008 to 2009) | |||||||
R-CVP × two cycles (2009) | |||||||
Lenalidomide (2009) | |||||||
PCR × two cycles (5/18/2010 to 6/18/2010) | |||||||
Bendamustine × one cycle (7/31/10 to 8/1/10) pre-CART19 | |||||||
02 | 77/M del (17)(p13)* | Alemtuzumab × 16 weeks (6/2007) | Hypercellular >95% CLL | 2.75 × 1011 CLL cells (day −1) | 1.2 × 1012 to 2.0 × 1012 CLL cells (day −24) | 5.8 × 108 (1.0 × 107/kg) | PR (7 months) |
Alemtuzumab × 18 weeks (3/2009) | 3.2 × 1012 CLL cells (day −47) | ||||||
Bendamustine/rituximab: | |||||||
7/1/2010 (cycle 1) | |||||||
7/28/2010 (cycle 2) | |||||||
8/26/2010 (cycle 3) pre-CART19 | |||||||
03 | 64/M del (17)(p13)† | R-Fludarabine × two cycles (2002) | Hypercellular 40% CLL | N/A | 3.3 × 1011 to 5.5 × 1011 CLL cells (day −10) | 1.4 × 107 (1.46 × 105/kg) | CR (10+ months) |
R-Fludarabine × four cycles (10/06 to 1/07) | 8.8 × 1011 CLL cells (day −1) | ||||||
R-Bendamustine × one cycle (2/09) | |||||||
Bendamustine × three cycles (3/09 to 5/09) | |||||||
Alemtuzumab × 11 weeks (12/09 to 3/10) | |||||||
Pentostatin/cyclophosphamide (9/10/10) pre-CART19 |
UPN 02 karyotype [International System for Human Cytogenetic Nomenclature (ISCN)]: 45,XY,del(1)(q25),+del(1)(p13),t(2;20)(p13;q11.2),t(3;5)(p13;q35),add(9)(p22),?del(13)(q14q34), −14,del(17) (p13)[cp24].
UPN 03 karyotype (ISCN): 46,XY,del(17)(p12)[18]/44~46,idem,der(17)t(17;21)(p11.2;q11.2)[cp4]/40~45,XY, −17[cp3].
See the Supplementary Material for methods of tumor burden determination.