Table 3.
CRS grading systems used in published FMC63 (CD19) CAR-T cell clinical trials.
| NCT ID | CAR Name | CAR Domain Structure | No. of Patients | CRS Grading System | Neurotoxicity Grading System | ||||
|---|---|---|---|---|---|---|---|---|---|
| ScFv | Hinge | TM | Costim | Signal | |||||
| NCT02842138 | CD19-BBz(86) | FMC63 | CD8α | CD8α | 41BB | CD3ζ | 7 | CTCAE v4.03 [57] | CTCAE v4.03 [57] |
| NCT02842138 | CD19-BBz(86) | FMC63 | CD8α | CD8α | 41BB | CD3ζ | 13 | CTCAE v4.03 [57] | CTCAE v4.03 [57] |
| NCT02030834 | CTL-019 | FMC63 | CD8α | CD8α | 41BB | CD3ζ | 28 | Penn grading system [41] | CTCAE v3.0 [58] |
| NCT02445248 | CTL-019 | FMC63 | CD8α | CD8α | 41BB | CD3ζ | 111 | Penn grading system [41] | CTCAE v4.03 [57] |
|
NCT01626495 NCT01029366 |
CTL-019 | FMC63 | CD8α | CD8α | 41BB | CD3ζ | 30 | Penn grading system [41] | CTCAE v3.0 [58] |
| NCT02435849 | CTL-019 | FMC63 | CD8α | CD8α | 41BB | CD3ζ | 75 | MedDRA and CTCAE v4.03 [57] | MedDRA and CTCAE v4.03 [57] |
| NCT02631044 | JCAR017 | FMC63 | CD8α | CD8α | 41BB | CD3ζ | 268 | Lee et al. 2014 [60] | CTCAE v4.03 [57] |
| NCT01860937 | 19-28z | FMC63 | CD28 | CD28 | CD28 | CD3ζ | 25 | CTCAE v4.0 | CTCAE v4.0 |
| NCT01044069 | 19-28z | FMC63 | CD28 | CD28 | CD28 | CD3ζ | 53 | Lee et al. 2014 [60] | CTCAE v4.03 [57] |
| NCT00466531 | 19-28z | FMC63 | CD28 | CD28 | CD28 | CD3ζ | 16 | CTCAE v3.0 (<2009) [58] CTCAE v4.0 (>2009) |
CTCAE v3.0 (<2009) [58] CTCAE v4.0 (>2009) |
| NCT01840566 | 19-28z | FMC63 | CD28 | CD28 | CD28 | CD3ζ | 15 | ASBMT | CTCAE v4.03 [57] |
| NCT02601313 | KTE-X19 | FMC63 | CD28 | CD28 | CD28 | CD3ζ | 68 | Lee et al. 2014 [60] | CTCAE v4.03 [57] |
| NCT02348216 | KTE-C19 | FMC63 | CD28 | CD28 | CD28 | CD3ζ | 101 | Lee et al. 2014 [60] | CTCAE v4.03 [57] |
| NCT00924326 | CAR-19 | FMC63 | CD28 | CD28 | CD28 | CD3ζ | 17 | CTCAE v3.0 [58] | CTCAE v3.0 [58] |
| NCT01593696 | FMC63-28z | FMC63 | CD28 | CD28 | CD28 | CD3ζ | 21 | CTCAE v4.02 | CTCAE v4.02 |
| NCT02963038 | SENL-B19 | FMC63 | CD28 | CD28 | 41BB | CD3ζ | 10 | CTCAE v4.0 | CTCAE v4.0 |
| NCT01865617 | - | FMC63 | IgG4 | CD28 | 41BB | CD3ζ | 32 | CTCAE v4.03 [57] | CTCAE v4.03 [57] |
ASBMT, American Society for Blood and Marrow Transplantation Consensus Criteria; CTCAE, National Cancer Institute Common Terminology Criteria for Adverse Event; MedDRA, Medical Dictionary for Regulatory Authorities.