ADP-A2M4CD8 as Monotherapy or in Combination with Nivolumab in HLA-A2+ Subjects with MAGE-A4 Positive Tumors (SURPASS)
A Phase 1 Dose Escalation Study to Assess Safety and Efficacy Of ADP-A2M4CD8 as Monotherapy or in Combination with Nivolumab or Pembrolizumab in HLA-A2+ Subjects with MAGE-A4 Positive Tumors (SURPASS)
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Djuro, Victor
Trial Phone: 321.841.9821 ; 321.841.7477
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IRB No: 22.257.12
Protocol Abbrev: ADP-0055-001
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: ADP-0055-001
Treatment: Experimental: Autologous genetically modified ADP-A2M4CD8 cells Genetic: Autologous genetically modified ADP-A2M4CD8 cells alone or in combination with nivolumab every four weeks Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1 alone or in combination with nivolumab 480 mg IV every four weeks
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT04044859
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Objective
To evaluate the safety and tolerability of autologous genetically modified T cells (ADP-A2M4CD8) as monotherapy or in combination with nivolumab in subjects with HLA-A*02 and MAGE-A4 positive inoperable locally advanced or metastatic tumors
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Key Eligibility
Inclusion criteria
• Age ≥18 and ≤ 75 years
• Subject is positive for at least 1 HLA-A*02 inclusion allele
• Histologically or cytogenetically confirmed diagnosis of urothelial cancer, esophageal, esophagogastric junction (EGJ) cancer, gastric cancer, non-small cell lung carcinoma (NSCLC), head and neck or ovarian cancer, endometrial cancer, melanoma
• Measurable disease according to RECIST v1.1 prior to leukapheresis and lymphodepletion.
• Tumor shows MAGE-A4 expression as confirmed by central laboratory
• ECOG Performance Status of 0 or 1.
• Left ventricular ejection fraction (LVEF) ≥50% or the institutional lower limit of normal range, whichever is lower Note: other protocol defined Inclusion/Exclusion criteria may apply
• Subjects must have ≥ 90% room air oxygen saturation at rest at Screening (within 7 days of leukapheresis) and at Baseline.
