Do not make unauthorized copies. Demographics are shown in Table 5. No Grade 3 Vigil related toxic effect was observed at dose levels of 1x10e6 (n=5) or 1x10e7 (n=5) cells/injection. No unexpected toxic effect known to be related to irinotecan/temozolomide combination was observed. Table 6 depicts the ≥Grade 3 adverse events reported to date (out of 175 events). Seven (EW -167-3010, EW-167- 3012, EW-167-3003, EW-167-3006, EW-167-3011, EW-167-3013, EW-002-3005) of the 10 patients were available to assess durable (≥ 6 months) progression free response. One (EW- 167-3014) is alive and doing well but has not yet reached 6- month evaluation. Additionally, the comparison of 1 x 10 6 cell/ml (n=3) vs 1 x 107 cells/ml (n=4) did not reveal any differences in safety or efficacy, measured as OS from time of treatment start of mean 169 days (1 x 106 cells/ml) vs. 185 days (1 x 107 cells/ml). Table 5 . Demographics of subjects enrolled into Part 2 of CL-PTL-121. Intent to treat population Evaluable patients for response (≥6mo PFS) Number of patients 10 7 Age Mean 25 24 Range 12 to 46 12 to 46 Gender Female 5 4 Male 5 3 Ethnicity Caucasian 9 6 Hispanic/Latino 1 1 Other 0 0 Lines of prior systemic T reatment Mean 4 5 Range 1 to 13 1 to 13 Ph III Ewing’s Sarcoma Vigil ± Irinotecan +Temozolomide IND 014205 CL-PTL-130 Version: 03 Page 36 of 74 Confidential and proprietary information of Gradalis, Inc. Effective: 05-DEC-2018 It is the user’s responsibility to verify adequate training before executing a document.