M.D. Anderson Cancer Center
To find a recommended dose of attIL2-TIL cell therapy that can be given to participant with either relapsed or metastatic sarcomas (has come back or spread to other parts of the body, respectively). To further test the dose found in Part A to see if it can help to control liposarcoma growth.
Primary Objectives Part A. Determine the safety, maximum tolerated dose and/or recommended phase 2 dose of T cell membrane-anchored tumor- targeted IL12 (attIL12)-TIL cell therapy in combination with cyclophosphamide in participants with advanced/metastatic soft tissue or bone sarcomas Part B. Characterize the safety and tolerability and assess preliminary efficacy of attIL12 TIL cells in combination with cyclophosphamide by evaluating the 4-month progression free survival rate (PFS 4 months) in participants with recurrent unresectable liposarcoma Secondary Objectives 1\) Evaluate the anti-t…
Inclusion Criteria: 1. Age ≥ 12 years old 2. Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma scheduled to undergo resection or biopsy as part of standard of care 3. Liposarcoma expansion cohort: histologically confirmed unresectable recurrent/metastatic liposarcoma scheduled to undergo resection or biopsy as part of standard of care 4. Participants undergoing resection should have other measurable disease or be high risk for recurrence within 12 month per investigator assessment and has prior approval by PI. 5. Measurable disease according to RECIST 1.1 pre…
Given by IV
Given by IV
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