Screening Protocol for Tumor Antigen Expression Profiling and HLA Typing for Eligibility Determination
A Screening Protocol to Determine Tumor Antigen Expression and HLA Sub-Type for Eligibility Determination for Clinical Trials Evaluating the Safety and Efficacy of Autologous T-Cells Expressing Enhanced TCRS in Subjects with Solid or Hematological Malignancies.
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Djuro, Victor; Rodriguez Saavedra, Carlis M; Frankos, Marie; Durand, Jennifer; Simoni, Christine; Ribacchi, Stephanie; Casillas, Bridey L; Caldwell, Chloe M; Waris, Seema; Bobe Cortes, Estefania
Trial Phone: 321.841.9821 ; 321.841.7477 ; 321.841.6764 ; 321.841.7303 ; 321.843.2026 ; 321.841.7293 ; 321-841-1077 ; 321.841.8284 ; (321)841.1107 ; 321.841.1907 ; 321.841.6626
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IRB No: 23.052.03
Protocol Abbrev: ADP-0000-001
Principal Investigator: Sajeve Samuel Thomas, MD
Age Group: Adult
Secondary Protocol No: ADP-0000-01
Treatment: N/A Screening Protocol for ADP-0055-001
ClinicalTrials.gov ID: NCT02636855
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Objective
This multicenter screening study will be conducted in order to determine a subject’s tumor antigen expression profile and HLA subtype, and subsequent eligibility for Adaptimmune sponsored clinical treatment trials studying the safety and efficacy of autologous genetically modified T cells engineered with enhanced TCRs targeting specific antigens. No treatment intervention will occur as part of this screening study.
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Key Eligibility
-Histologically or cytologically confirmed diagnosis of advanced solid or hematologic malignancy or recurrent disease, as described in the respective Adaptimmune clinical treatment protocol (including, but not limited to myeloma, melanoma, NSCLC, head and neck, gastric and bladder cancer)
-Male or female ≥ 18 to ≤75 years of age
-Life expectancy > 3 months
-Ability to provide a blood sample
-Ability to provide one of the following tumor tissue samples:
i. formalin-fixed, paraffin-embedded (FFPE) tumor block or tissue sections from a current lesion/the most current setting, OR
ii. a fresh biopsy is feasible, OR;
iii. a FFPE archival primary tumor block or tissue sections
