Table 3.
Summary of treatment regimen and toxicity for patients receiving gene-modified T cells
| Patient | Cycle no. | No. T cells ×10− 9 | No. IL-2 injections | Grades of adverse events | Grade 1 and 2 toxicity events | Grade 3 and 4 toxicity events |
|---|---|---|---|---|---|---|
| 1 | 1 | 3.0 | 6 | 1, 2, 3, 4 | HB, FAT, NAU, PU, PE | LEU, HYP, PCD |
| 2 | 3.0* | 5 | 2, 3 | ED | RIG | |
| 3 | 10.0 | 3 | 2, 3 | ED, LEU, PCD, PU, PE | HB, HYP | |
| 2 | 1 | 3.0† | 5 | 1, 2 | PCD, FAT, NAU, BIL, PU | |
| 2 | 9.0 | 4 | ||||
| 3 | 47.0† | 4 | ||||
| 3 | 1 | 3.0 | 5 | 3 | DIA, FAT | |
| 2 | 10.0 | 3 | 2 | LUO | ||
| 3 | 17.5 | 1 | 3 | HYP, STC | ||
| 4 | 1 | 3.0 | 5 | |||
| 2 | 11.4† | 1 | 3 | DYS | ||
| 3 | 21.9† | 0 | ||||
| 5 | 1 | 3.0 | 3 | 2 | ASC | |
| 6 | 1 | 28.57† | 6 | 2 | FAT, DIA | |
| 2 | 11.0 | 6 | 2 | FAT | ||
| 7 | 1 | 22.0† | 0 | 2, 4 | RIG, VOM | DYS‡ |
| 8 | 1 | 44.0† | 2 | 3 | HYP | |
| 2 | 43.5 | 1 | 2 | DYS | ||
| Cycle no. | No. T cells × 10− 9 | No. allo Immunizations§ | No. allo cells × 10− 9 | Grades of adverse events | Grade 1 and 2 toxicity events | |
|
| ||||||
| 9 | 1 | 46.5 | 2 | 4.55 | 1, 2 | ISR, URT, DYS |
| 2 | 169.0 | 2 | 6.5 | None | ||
| 10 | 1 | 13.17† | 2 | 4.5 | 1, 2 | RIG, ISR, NAU |
| 2 | 50.0 | 2 | 7.0 | None | ||
| 11 | 1 | 4.0 | 2 | 7.8 | 2 | ISR |
| 12 | 1 | 11.7 | 2 | 7.32 | 1 | ISR |
| 13 | 1 | 36.7 | 2 | 6.72 | None | |
| 14 | 1 | 9.0 | 2 | 7.45 | 1, 2 | HYP, RIG, FAT, ISR, NAU, VOM |
Abbreviations: ASC, ascites; HB, hemoglobin; PE, pleural effusion; BIL, bilirubin increased; HYP, hypotension; PU, pulmonary; DIA, diarrhea; LEU, leukopenia; RIG, rigors; DYS, dyspnea; LUO, low urine output; STC, sinus tachycardia; ED, Edema; NAU, nausea; URT, urticaria; FAT, fatigue; PCD, platelet count decreased; VOM, vomiting; ISR, injection site reaction (allogeneic immunization).
No progression to higher dose in this cycle due to grade 4 toxicity in previous cycle.
Some of these cells were labeled with 111In for trafficking.
Off protocol after one cycle due to dyspnea concerns.
Dose divided into two to four injections given on day 1 and 8 following MOv-γ T cells.