First-in-human Study of OT-A201 in Patients With Selected Hematological Malignancies and Solid Tumors

Main Inclusion Criteria:

• Histologically or cytologically confirmed relapsed/refractory hematological malignancy or advanced/metastatic solid cancer
• Measurable disease
• Have had all available therapeutic standards for their disease
• Willingness to undergo baseline biopsy/bone marrow aspiration in case biopsy was not collected after completion of the most recent prior therapy
• ECOG performance status ≤ 1
• Life expectancy > 3 months as assessed by the investigator
• Acceptable clinical lab results

Main Exclusion Criteria:

• Systemic steroids at a daily dose of > 10 mg of prednisone or equivalent within 28 days before study treatment. Transient use of steroids for other medical condition may be allowed
• Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previous therapies not resolved except vitiligo, stable neuropathy up to grade 2, hair loss, and stable endocrinopathies with substitutive hormone therapy
• Within 4 weeks of major surgery
• Documented history of active autoimmune disorder requiring systemic immunosuppressive therapy within the last 12 months
• Prior solid organ transplant
• Primary or secondary immune deficiency
• Active and uncontrolled infection requiring intravenous antibiotic or antiviral treatment
• Seropositive (except after vaccination or confirmed cure for hepatitis) for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
• Clinically significant disease