Table 1.
Lentiviral and Retroviral Vector Lots, RCL/R Monitoring
| Investigational Product | Vector Type | Envelope | Promoter | Transgene | Number of Vector Lots |
NCT Number(s) | |||
|---|---|---|---|---|---|---|---|---|---|
| Produced | Tested for RCR/L via Biological Method | Tested for RCR/L via Molecular Method | Used for T Cell Product Manufacture | ||||||
| CTL019 | lentivirus, third generation, SIN | VSV-G | EF-1a | murine anti-CD19 scFv with 4-1BB and CD3ζ signaling domains | 9 | 9 | 8 | 7 | NCT02030847, NCT01029366, NCT01626495, NCT01747486, NCT02135406, NCT02030834, NCT02465983 |
| CTL119 | lentivirus, third generation, SIN | VSV-G | EF-1a | humanized anti-CD19 scFv with 4-1BB and CD3ζ signaling domains | 2 | 2 | 1 | 3 | NCT02374333, NCT02640209, NCT02030834 |
| CART-meso | lentivirus, third generation, SIN | VSV-G | EF-1a | murine anti-mesothelin scFv with 4-1BB and CD3ζ signaling domains | 1 | 1 | 1 | 2 | NCT02465983, NCT02159716 |
| CART-BCMA | lentivirus, third generation, SIN | VSV-G | EF-1a | human anti-BCMA scFV with 4-1BB and CD3ζ signaling domains | 1 | 1 | 0 | 1 | NCT02546167 |
| CART-EGFRvIII | lentivirus, third generation, SIN | VSV-G | EF-1a | humanized anti-EGFRvIII scFV with 4-1BB and CD3ζ signaling domains | 1 | 1 | 1 | 1 | NCT02209376 |
| VRX-496 | lentivirus, third generation, SIN | VSV-G | HIV-1 LTR | antisense sequence targeting HIV env | 1 | 1 | 0 | 1 | NCT00295477 |
| CD4zeta | retrovirus, second generation | aMLV | PGK | human CD4 transmembrane and extracellular domains fused with CD3ζ signaling domain | 1 | 1 | 0 | 1 | NCT01013415 |
| MazF | retrovirus, second generation | GaLV | HIV-1 LTR | MazF endoribonuclease | 1 | 1 | 0 | 1 | NCT01787994 |
| Lentivirus totals | 15 | 15 | 11 | 15 | |||||
| Retrovirus totals | 2 | 2 | 0 | 2 | |||||
SIN, self-inactivating; VSV-G, vesicular stomatitis virus glycoprotein; LTR, long terminal repeat; PGK, phosphoglycerol kinase; aMLV, amphotropic murine leukemia virus; GaLV, gibbon ape leukemia virus.