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 hematologicalmalignancy 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 notcollected 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 28days before study treatment. Transient use of steroids for other medical conditionmay be allowed

• Ongoing immune-related adverse events irAEs and or AEs ≥ grade 2 from previoustherapies 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 systemicimmunosuppressive therapy within the last 12 months

• Prior solid organ transplant

• Primary or secondary immune deficiency

• Active and uncontrolled infection requiring intravenous antibiotic or antiviraltreatment

• Seropositive (except after vaccination or confirmed cure for hepatitis) for humanimmunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)

• Clinically significant disease