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the nih clinical center

| Table 8. Toxicity of Treatment with Interleukin-2   |       |     |       |      |      |      |       |       |
|-----------------------------------------------------|-------|-----|-------|------|------|------|-------|-------|
| Interleukin-2 Plus                                  | Alone | TNF | a IFN | MoAB | CYT  | LAK  | TIL   | Total |
| 155                                                 | 38    | 128 | 32    | 19   | 214  | 652® |       |       |
| Number of Patients                                  | ,     | 66  |       |      |      |      |       |       |
| 236                                                 | 210   | 35  | 348   | 95   | 1039 |      |       |       |
| Number of Courses                                   | 85    | 30  |       |      |      |      |       |       |
| Chills                                              | 3     |     |       |      |      |      |       |       |
| 75                                                  | 16    | 68  | 8     | 00   | 191  | 39   |       |       |
| Pruritus                                            | 53    | 9   | 26    | 2    | 2    | 82   | 6     | 180   |
| Necrosis                                            |       |     | 2     |      | s    |      |       |       |
| Anaphylaxis                                         |       | l   |       | i    |      |      |       |       |
| Mucositis (requiring liquid diet)                   | 12    |     |       |      |      |      |       |       |
| 6                                                   | -1    |     | 12    | 2    | 30   |      |       |       |
| Alimentation not possible                           | l     | l   |       | 4    |      |      |       |       |
| Nausea and vomiting                                 | 162   | 42  | 17    | 14   | 20   | 263  | 48    | 666   |
| Diarrhea                                            | 144   | 38  | 98    | 15   | 13   | 250  | 38    | 596   |
| Hyperbilirubinemia (maximum/mg %)                   |       |     |       |      |      |      |       |       |
| 2.1-6.0                                             | 126   | 49  | 97    | 21   | 18   | 190  | 46    | 547   |
| 6.1-10.0                                            | .49   | .3  | 12    | 8    | 19   | 72   | 26    | 179   |
| 10.14                                               | 26    | i   | l     | i    | 40   | 83   |       |       |
| 4                                                   | 8     |     |       |      |      |      |       |       |
| Oliguria                                            |       |     |       |      |      |      |       |       |
| <80 ml/8 hours                                      | 81    | 37  | 67    | 14   | 9    | 114  | 25    | 347   |
| <240 ml/24 hours                                    | 19    | 2   | دع    | i    | 12   | s    | 42    |       |
| Weight gain (% body weight)                         |       |     |       |      |      |      |       |       |
| .0.0-5.0                                            | 106   | 23  | 65    | 8    | 9    | 17   | 49    | 377   |
| 5.1-10.0                                            | 78    | 41  | 11    | 2    | 10   | 148  | 26    | 436   |
| 10.1-15.0                                           | 43    | 17  | 26    | 3    | 9    | 62   | 15    | 175   |
| 15.1-20.0                                           | 7     | 3   | 0     | i    | i    | I S  | 3     | 38    |
| 20.1+                                               | 2     | l   | i     | i    | 6    | 2    | 13    |       |
| Elevated creatinine (maximum/mg %)                  | 148   | 43  | 121   | 20   | 14   | 237  | 54    | 637   |
| 2.1–6.0                                             |       |     |       |      |      |      |       |       |
| 6.1-10.0                                            | 21    | -I  | 14    | 3    | .341 | 12   | 85    |       |
| 10.1+                                               | 15    | l   | 1     |      | l    | 2    | I     | 10    |
| Hematuria (gross)                                   | (     | i   | l     | l    | 2    | l    | 2     |       |
| Edema (symptomatic nerve or vessel                  |       |     |       |      |      |      |       |       |
| compression)                                        | 4     | l   | 6     | l    | 7    | l    | 17    |       |
| Tissue ischemia                                     | i     | l   | i     | i    | i    | 2    |       |       |
| Resp. distress:                                     |       |     |       |      |      |      |       |       |
| not intubated                                       | 17    |     | 19    | 4    | l    | 28   | 7     | 67    |
| intubated                                           | is    | o   | 3     | 12   | s    | 41   |       |       |
| l                                                   |       |     |       |      |      |      |       |       |
| Bronchospasm                                        | 2     | l   | 2     | l    | 4    |      | 9     |       |
| l                                                   |       |     |       |      |      |      |       |       |
| Pleural effusion (requiring                         |       |     |       |      |      |      |       |       |
| thoracentesis)                                      | 4     | i   | i     | 2    | 8    | i    | 17.   |       |
| Somnolence                                          | 29    | 2   | 22    | 6    | 2    | .45  | 88    | 14    |
| s                                                   |       |     |       |      |      |      |       |       |
| Coma .                                              | 19    | 3   | 18    | 2    | .8   | 33   |       |       |
| Disorientation                                      | 52    | 50  | 89    | 10   | 215  |      |       |       |
| d                                                   |       |     |       |      |      |      |       |       |
| Hypotension (requiring pressors)                    | 19    | 16  | 40    | 17   | 12   | 259  | 45    | 508   |
| Angina                                              | s     | i   | 8     | 8    | 2    |      |       |       |
| l                                                   |       |     |       |      |      |      |       |       |
| Myocardial infarction                               | 4     | i   | l     | l    | l    | l    | 6     |       |
| Arrythmias                                          | 15.   | 2   | 13    | 3    | .39  | 6    | 78    |       |
| l                                                   |       |     |       |      |      |      |       |       |
| Anemia requiring transfusion (number)               |       |     |       |      |      |      |       |       |
| units transfused)                                   |       |     |       |      |      |      |       |       |
| 1-15                                                | 77    | 16  | 553   | 9    | 6    | 176  | 40    | 377   |
| 6–10                                                | 22    |     | s     | 3    | 2    | 53   | 9     | 95    |
| 1-15                                                | 4     | l   | i     | l    | l    | IS   | 4     | 24    |
| 16+                                                 | i     | i   | i     | l    | i    | 11   | i     | 14    |
| Thrombocytopenia (minimum/mm 2 )                    |       |     |       |      |      |      |       |       |
| < 20.000                                            | 28    | 1   | 2     | 4    | 6    | .71  | 196   | 131   |
| 20,001-60,000                                       | 82    | 1   | 62    | 14   | 12   | 150  | 30    | .361  |
| 60,001-100,000                                      | 53    | 36  | 76    | 11.  | 8    | 79   | 22    | 285   |
| Central line sepsis                                 | 13    | -   | 7     | l    | 4    | 36   | 13 12 | 63    |
| Death                                               | 4     |     | 1.    | 3    | 10   |      |       |       |
| - Eleven patients are in two protocols.             |       |     |       |      |      |      |       |       |  
A b brevi ate d Title: A nti N Y E S O - 1 m T C R P B L  
Versi o n ate: A u g ust 6, 2 0 1 8
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1 3. 5 p p

Date of pre parati o n of fi nal pr o d uct:  
Patie nt:  
T ests perf or me d o n fi nal pr o d uct:  
| Test                                                                                                                                                      | Met h o d                                        | Li mits        | Res ult   | Tests  perf or me d by   | I niti als/ D ate   |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|----------------|-----------|--------------------------|---------------------|
| Cell via bilit y                                                                                                                                          | tr y pa n bl ue e xcl usi o n                    | > 7 0 %        |           |                          |                     |
| T otal via ble cell  n u m ber                                                                                                                            | vis ual micr osc o pic c o u nt                  | > 1 x 1 0      |           |                          |                     |
| T u m or reacti vit y                                                                                                                                     | F N release vs. pe pti de                        |                |           |                          |                     |
| p ulse d T 2 cells                                                                                                                                        | 2 0 0 p g/ m L                                   |                |           |                          |                     |
| T C R e x pressi o n                                                                                                                                      | F A C S a nal ysis of t he  tra ns d uce d cells | P B L, > 1 0 % |           |                          |                     |
| Micr o bi ol o gical  st u dies                                                                                                                           | gra m stai n 1, 3,                               | n o micr oor ga nis ms see n                |           |                          |                     |
| aer o bic c ult ure 3, 4                                                                                                                                  | n o gr o wt h                                    |                |           |                          |                     |
| f u n gal c ult ure3, 4                                                                                                                                   | n o gr o wt h                                    |                |           |                          |                     |
| a naer o bic c ult ure 3, 4                                                                                                                               | n o gr o wt h                                    |                |           |                          |                     |
| m yc o plas ma test                                                                                                                                       | ne gati ve                                       |                |           |                          |                     |
| E n d ot o xi n                                                                                                                                           | li m ul us assa y                                | < 5 E. U./ k g |           |                          |                     |
| R C R                                                                                                                                                     | S + L - Assa y 4                                 | ne gati ve     |           |                          |                     |
| R C R                                                                                                                                                     | P C R 6                                          |                |           |                          |                     |
| P erf or me d o n sa m ple of t h e fi n al pr o d u ct i m me diatel y pri or t o i nf usi o n. Res ults are a vaila ble at t h e ti me of i nf usi o n. |                                                  |                |           |                          |                     |  
P erf or me d o n sa m ple of t h e fi n al pr o d u ct i m me diatel y pri or t o i nf usi o n. Res ults are a vaila ble at t h e ti me of i nf usi o n.  
P erf or me d 2 1 0 p ost tra ns d u cti o n. Res ults are a vaila ble at t h e ti me of i nf usi o n.  
P erf or me d 2 4 d a ys pri or t o i nf usi o n. Res ults are a vaila ble at t h e ti me of i nf usi o n b ut ma y n ot b e d efi niti ve.  
Sa m ple c ollecte d fr o m t h e fi n al pr o d u ct pri or t o i nf usi o n. Res ults will n ot b e a vaila ble b ef ore cells are i nf use d i nt o t h e p atie nt.  
5 P erf or me d 2 1 0 d a ys pri or t o i nf usi o n. Res ults are a vaila ble at t h e ti me of i nf usi o n.  
6 P erf or me d o n sa m ple a p pr o xi matel y 1 4 d a ys pri or t o i nf usi o n. Res ults are a vaila ble at t h e ti me of i nf usi o n.  
Pre pare d b y: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Q C si g n off: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Date: _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _  
Q ualifie d Cli nical or La b orat or y S u per vis or