The protocol will be monitored internally by the Principal Investigator. The protocol will be m onitored externally by the SKCCC CRO in accordance with SKCCC guidelines. Additional data and safety monitoring oversight will also be performed by the SKCCC Sa fety Monitoring Committee (SMC - as defined in the DSMP) and a Medical Expe rt Committee (MEC) as detailed below. The Medical Expert Committee (MEC) for this clinical study cont ains three medical oncologists from other disciplines who are not affiliated with this clinical trial protocol. The MEC will review safety data on at least a semi-annual basis. The MEC will provide a written summary of each as sessment to the IND Sponsor after each meeting. In turn, the study team will forward these summaries to the JHU and other participating site IRBs and JHU SKCCC SM C. The operating plan of the MEC will be as follows:  Meetings will be held at least semi-annua lly, and potentially more frequently if needed.  Meetings will be conducted in-person or via video/teleconference, with a participant sign-in sheet collected at each meeting.  Approximately one week prior to each MEC meeting, the study team will submit the following items to MEC personnel for review and discussion at the meeting (The PI may join the MEC meeting in order to answer a ny questions the MEC might have): o A summary of the clinical trial’s progress to date; o The latest IRB-approved consent document; o A summary of all adverse events, se rious adverse events, deaths, and withdrawals to date; Note that the MEC reserves the right to halt trial accrual or all st udy activity if, after review, serious safety concerns warrant this action. If the MEC halts study accrual or all study activity, then the study team must notify the JHU SKCCC SMC, JHU IRB, JHU IBC, RAC and the FDA immediately. Dr. Lei Zheng will be holding the IND fo r this study. He will comply with all regulated reporting requir ements to the FDA.