Table 1.
Characteristics of Patients and Administered T Cells
| Patient No. | Age(years) | Sex | Sites of Disease | Prior Treatment | No. of Cells(×109) | No. of IL-2 Doses | % of CD3 |
NY-ESO-1 Tetramer Positive |
Vβ13.1 Positive(% of CD3) | Tumor Cell Targets (pg/mL IFN-γ)* |
Response† | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CD8 | CD4 | % of CD8 | % of CD4 | NY-ESO-1 Positive | NY-ESO-1 Negative | |||||||||
| Melanoma | ||||||||||||||
| 1 | 52 | M | ln | R, S, I | 130 | 6 | 97 | 2 | 86 | 64 | 94 | 515 | < 30 | PR (8) |
| 2 | 60 | F | sc, lu | S, I | 71 | 6 | 82 | 17 | 76 | 53 | 90 | 3,890 | < 30 | PD |
| 3 | 30 | F | bo, ln, panc, sb | R, S, I | 47 | 1 | 98 | 1 | 80 | 65 | 91 | 11,978 | 130 | PD |
| 4 | 56 | M | lu, ki | R, S, I | 50 | 7 | 91 | 9 | 80 | 74 | 94 | 11,230 | < 30 | CR (22+) |
| 5 | 32 | M | ln | S, C, I | 64 | 4 | 98 | 2 | 85 | 76 | 94 | 26,019 | 288 | CR (20+) |
| 6 | 38 | M | ln | S, I | 51 | 7 | 93 | 7 | 87 | 79 | 94 | 28,907 | 536 | PR (3) |
| 7 | 47 | M | ln, lu | R, S, I | 23 | 7 | 96 | 4 | 70 | 58 | 90 | 9,577 | 178 | PD |
| 8 | 39 | F | ln, br, lu | R, S, C, I | 38 | 8 | 68 | 32 | 78 | 70 | 94 | ND | ND | PD |
| 9 | 51 | F | lu, ln, li | S, C, I | 31 | 10 | 94 | 6 | 83 | 69 | 96 | 11,952 | 35 | PD |
| 10 | 61 | M | ln, li, spl, lu, bo | R, S, C, I | 16 | 8 | 84 | 16 | 79 | 56 | 92 | 16,063 | 49 | PD |
| 11 | 46 | M | lu, li | R, S, I | 37 | 6 | 93 | 7 | 63 | 58 | 85 | 5,795 | < 30 | PR (9+) |
| Synovial cell sarcoma | ||||||||||||||
| 12‡ | 20 | M | lu, bo | R, S, C, I | 83 | 5 | 82 | 8 | 77 | 64 | 91 | 10,065 | 117 | PR (10) |
| 13‡ | 37 | F | lu | R, S, C | 50 | 8 | 90 | 5 | 78 | 78 | 93 | 11,656 | 94 | PR (18) |
| 14‡ | 47 | F | lu, ln | R, S, C | 56 | 8 | 89 | 11 | 81 | 76 | 91 | 10,836 | 50 | PR (5) |
| 15‡ | 19 | M | lu | R, S, C, I | 16 | 5 | 46 | 40 | 67 | 63 | 89 | 5,371 | < 30 | PD |
| 16 | 30 | M | pl, hi | S, C | 59 | 5 | 92 | 8 | 74 | 57 | 88 | 6,512 | 199 | PR (8) |
| 17 | 40 | M | pl, hi | R, S, C | 52 | 5 | 81 | 18 | 78 | 69 | 92 | 8,098 | < 30 | PD |
Abbreviations: IL-2, interleukin-2; IFN-γ, interferon gamma; M, male; ln, lymph node; R, radiation; S, surgery; I, immunotherapy; PR, partial response; F, female; sc, subcutaneous; lu, lung; PD, progressive disease; bo, bone; panc, pancreas; sb, small bowel; ki, kidney; CR, complete response; C, chemotherapy; br, brain; ND, not done; spl, spleen; pl, pleura; hi, hilum.
Overnight cocultures of infusion samples were carried out with HLA-A*0201–positive tumor cell lines that either expressed (624 mel) or did not express (526 mel) NY-ESO-1.
In parentheses are the durations of response in months from the day of cell infusion.
Patients 12, 14, and 15 received one (patients 14 and 15) or two (patient 12) additional infusions of 1G4-α95LY–transduced T cells but did not respond to the treatments. Patient 13 received a second infusion of transduced T cells 9 months after the initial treatment and demonstrated a partial response lasting 18 months from the time of the initial treatment with transduced T cells.