A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma
M.D. Anderson Cancer Center
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.
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…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Age .12 years old 2. Histologically-confirmed locally advanced or metastatic soft tissue or bone sarcoma 3. Osteosarcoma expansion cohort: histologically confirmed unresectable recurrent/metastatic osteosarcoma 4. Evaluable disease. 5. Patients must have received at least 1 prior line of systemic therapy for the treatment of sarcoma, unless no standard therapy exists for a specific sarcoma subtype 6. Prior Cancer Therapy . At least 3 weeks must have elapsed since the last cytotoxic chemotherapy or immunotherapy prior to leukapheresis/PBMC collection. * For targeted…
Interventions
- DrugCyclophosphamide
Given by IV (vein)
- DrugattIL2-T cells
Given by IV (vein)
Location
- M D Anderson Cancer CenterHouston, Texas