The purpose of this study is to assess the safety and tolerability and determine the recommended Phase 2 dose of AIC100 Chimeric Antigen Receptor (CAR) T cells in patients with relapsed/refractory poorly differentiated thyroid cancer and anaplastic thyroid cancer, including newly diagnosed.
The primary objective of this study is to assess the safety and tolerability of AIC100 CAR T Cells and determine the recommended Phase 2 dose of AIC100 in patients with relapsed/refractory poorly differentiated thyroid cancer and in patients with anaplastic thyroid cancer that are BRAF wild-type, including newly diagnosed, or BRAF mutant anaplastic thyroid cancer after failure of BRAF mutant specific therapy. Upon enrollment, patients will undergo apheresis for collection of autologous lymphocytes. The autologous T cells will be transfected and expanded in vitro to generate the AIC100 CAR T Cell product. After lymphodepleting chemotherapy, AIC100 CAR T Cells will be infused. The study drug product, AIC100, consists of autologous CAR T cells targeting intercellular adhesion molecule-1 (ICAM-1) on thyroid cancer. In addition, AIC100 cells express the somatostatin receptor subtype 2 (SSTR2), which should enable imaging of AIC100 CAR T Cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Autologous CAR T cells directed against ICAM-1
City of Hope National Medical Center, City of Hope Medical Center
Duarte, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Weill Cornell Medical College
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Incidence of overall Grade >=3 Adverse Events (AE) and Serious Adverse Events (SAE)
The number of Grade 3, 4 and 5 AEs and SAEs that occur throughout the study.
Time frame: Up to 1 year post-infusion
Incidence of anticipated AIC100 CAR T Cell related AEs, SAEs and adverse events of special interest (AESI) (infusion-related reactions, CRS, ICANS, HLH/MAS, TLS, new malignancies, AEs leading to death and DLT AEs)
The number of CAR T related adverse events that occur throughout the study, including AESIs, infusion-related reactions, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS), tumor lysis syndrome (TLS) and new malignancies.
Time frame: Up to 15 years post-infusion
Determine recommended phase 2 dose
The recommended phase 2 dose will be determined through the dose escalation process
Time frame: Up to 1 year post infusion
Assessment of presence and frequency of AIC100 CAR T cells in peripheral blood and tumor samples (when available)
Patients will be monitored for expansion and persistence of AIC100 CAR transgenes after infusion by vector copy number (VCN) analysis
Time frame: Up to 15 years post-infusion
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