A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies

Exclusion Criteria

• •1. Active non-hematologic malignancy other than lymphoid malignancies treated with immuno- or chemotherapy within the previous 12 months except active non-melanoma, non-invasive skin cancer will be allowed
• •2. Known, active Central Nervous System (CNS) involvement of disease requiring intrathecal therapy. Note: Patients with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening
• •3. Patient eligible for high dose chemotherapy and autologous stem cell transplant
• •4. Indolent non-Hodgkin lymphoma (iNHL)
• •5. Patients at high risk of Tumor Lysis Syndrome (TLS)
• •a. Bulky disease i. A unidimensional lesion greater than 10 cm and/or b. Lymphocyte count greater than 25,000 per µL
• •6. Receipt of any anti-cancer therapy within 14 days prior to Cycle 1 Day 1 (C1D1)
• •7. Uncontrolled active, untreated, or progressive infection
• •8. Receipt of any investigational agent or on study treatment within 30 days prior to C1D1
• •9. Females who are pregnant, test positive for pregnancy, or are breast-feeding during the Screening period, or intend to become pregnant or breast-feed during the course of the study or within 30 days after last dose of study drug
• •10. Serious intercurrent medical or psychiatric illness which, in the opinion of the Investigator, would interfere with the ability of the participant to complete the study
• •11. Active hepatitis B infection (based on positive surface antigen \[HBsAg\]), hepatitis C infection (based on Hepatitis C Virus (HCV) positive antibody \[HCV Ab\]), or human immunodeficiency virus (HIV-1 or HIV-2, based on positive antibody)
• •12. Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline EKG abnormality (e.g., QTcF \>470 msec)
• •13. Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack
• •14. Uncontrolled seizure disorder
• •15. Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason.