First-in-Human Study of ICT01 in Patients With Advanced Cancer

Exclusion Criteria

• •1. Any malignancy of Vγ9Vδ2 T cell origin
• •2. Any anti-tumor-directed drug therapy within 28 days or 5 times the elimination half-life (whichever is shorter) before study treatment (does not apply to patients receiving ICI for the combination arm)
• •3. Treatment with investigational drug(s) within 28 days before study treatment
• •4. Systemic steroids at a daily dose of \> 10 mg of prednisone, \> 2 mg of dexamethasone or equivalent, for the last 28 days and need for ongoing treatment.
• •5. Patients with rapidly progressing disease defined as advanced/metastatic, symptomatic, visceral spread, with a risk of life-threatening complications in the short term (e.g., during Screening Period/ treatment washout) that includes patients with massive uncontrolled effusions pleural, pericardial, peritoneal, pulmonary lymphangitis, and over 50% liver involvement
• •6. Ongoing immune-related adverse events (irAEs) and/or AEs ≥grade 2 not resolved from previous therapies except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with replacement hormone therapy.
• •7. Within 4 weeks of major surgery
• •8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy within the last 12 months
• •9. Primary or secondary immune deficiency
• •10. Active and uncontrolled infections requiring intravenous antibiotic or antiviral treatment