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Clinical Trial Summary

To find a recommended dose of attIL2-T cell therapy that can be given to patients with soft tissue or bone sarcomas and to see if it can help to control the disease.


Clinical Trial Description

Primary Objective: 1. Part A. Determine the safety, maximum tolerated dose and/or recommended phase 2 dose of adoptively transferred T cell membrane-anchored tumor targeted IL12 (attIL12)-T cells in combination with cyclophosphamide in patients with advanced/metastatic soft tissue or bone sarcomas 2. Part B. Characterize the safety and tolerability and assess preliminary efficacy of attIL12-armed T cells in combination with cyclophosphamide by evaluating the 4-month disease control rate (DCR4 months) in patients with recurrent unresectable osteosarcoma Secondary Objectives: 1. Evaluate the anti-tumor efficacy achieved following adoptive transfer of T cellmembrane-anchored tumor targeted IL12 (attIL12)-T cells in combination with cyclophosphamide in patients with advanced/metastatic soft tissue or bone sarcomas Exploratory Objectives: 1. Characterize the immune response following adoptive transfer of T cell membrane-anchored tumor targeted IL12 (attIL12)-T cells in paired in pre-treatment and on-treatment tumor specimens and peripheral blood samples 2. Assess FoxP3/CD33/CD8/IFNg expression in pre-treatment and on-treatment tumor specimens and correlate with clinical benefit/anti-tumor response 3. Determine changes in cell surface vimentin (CSV)-positive circulating tumor cells (CTCs) in peripheral blood before and after adoptive transfer of T cell membrane-anchored tumor targeted IL12 (attIL12)-T cells and correlate with clinical benefit/anti-tumor response ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05621668
Study type Interventional
Source M.D. Anderson Cancer Center
Contact John Livingston, MD
Phone (713) 792-3626
Email jalivingston@mdanderson.org
Status Recruiting
Phase Phase 1
Start date September 8, 2023
Completion date September 30, 2025

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