A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies
A Clinical Trial of BP1002 in Patients With Advanced Lymphoid Malignancies
This study evaluates the safety, pharmacokinetics, and efficacy of BP1002 (L-Bcl-2) antisense
 oligonucleotide in patients with advanced lymphoid malignancies. Up to 12 evaluable patients
 with a diagnosis of relapsed or refractory lymphoid malignancies are expected to participate.
Inclusion Criteria:

 1. Adults ≥18 years of age

 2. Patient has a life expectancy ≥ 3 month

 3. Patient has relapsed or refractory disease Relapsed lymphoma: Relapsed lymphoma is
 disease that has responded to treatment but then returns.

 Refractory lymphoma: Failure to achieve complete response at the end of therapy or
 progression within 6 months from completion of therapy

 4. Included Diseases

 -  DLBCL, including transformed lymphoma

 -  Mantle Cell Lymphoma

 -  PTCL

 -  CTCL

 -  CLL/SLL

 -  Follicular lymphoma

 -  Marginal zone lymphoma

 -  Hodgkin lymphoma (both classical and lymphocyte predominant)

 -  Waldenströms Macroglobulinemia

 5. Must has failed or is not a candidate for available therapies with reasonable
 likelihood of clinical benefit, which includes FDA approved products and standard of
 care regimens

 6. Therapy means at least three front lines of therapy including Hematopoeitic Stem Cell
 Transplant (HSCT and/or Chimeric Antigen Receptor (CAR) T cells, when applicable

 7. Females must be of non-childbearing potential, surgically sterile, postmenopausal, or
 practice adequate methods of contraception during the study

 8. Males must agree to use an adequate method of contraception during the study

 9. Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1, or 2

 10. Adequate hepatic and renal functions as defined by:

 -  Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper
 limit of normal (ULN); and

 -  Total bilirubin ≤1.5 times ULN; and

 -  Estimated glomerular filtration rate (eGFR) of at least 50ml/min. These
 estimations can be calculated using the following methods:

 -  Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation

 -  Cockcroft Gault equation

 -  Modification of Diet in Renal Disease (MDRD study equation)

 -  Creatinine clearance estimated by 24-hr urine collection for creatinine
 clearance

 11. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic
 treatment (with the exception of alopecia), based on Investigator assessment

 12. Willing and able to provide written informed consent

 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.