A Phase I Study of Intravenous CHO-H01 in Patients With Refractory or Relapsed Follicular Lymphoma

This is an interventional treatment trial for Follicular Lymphoma Read More

Inclusion Criteria:

• Age > 18 years Histologically confirmed, measurable, CD20 positive Follicular B cell lymphoma with an indication for treatment for which there is no therapy of curative potential or of higher priority
• Life expectancy of greater than 1 year
• ECOG performance status of 0 to 1
• Last dose of prior anti-cancer therapy must be at least 56 days (or two half-lives for proteins, whichever is greater) prior to the first administration of the study drug (to satisfy the recognized requirement of at least 5 times the terminal half-life period for most drugs currently used, including most receptor tyrosine kinase (RTK) inhibitors).
• Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Grade 0 or 1.
• Subject must be willing and able to provide fresh tumor at Screening. Subjects will be asked to provide additional needle biopsy samples on C2D8 and C4D8. Archival tumor biopsy (i.e., tissue block or series of ≈10 slides) is requested if available, and should be provided during the Screening period.
• Local laboratories may be used for standard laboratory assessments:

Adequate bone marrow function defined by: absolute neutrophil count (ANC) of ≥ 1.5 x 109/L, platelet count of ≥ 100.0 x 109/L, and hemoglobin ≥9.0 g/dL.

Adequate hepatic function defined by: serum total bilirubin < 2 mg/dl (unless resulting from hemolysis), aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x ULN (or ≤ 5 x ULN in subjects with liver metastases).

Adequate renal function assessed by: serum creatinine within normal limits, or creatinine clearance (by Cockcroft Gault formula) ≥ 50 mL/min for subjects in whom serum creatinine may not adequately reflect renal function.

• Must have measurable disease as described in Lugano Revised Criteria for Response. This assessment is the responsibility of the investigator who may use local radiology to support this assessment.
• Willing and able to understand and sign an informed consent form and to comply with all aspects of the protocol.
• Willingness to use effective methods of contraception.
• Adequate T cell immune parameters - CD4 >500/mcL, CD8 > 250/mcL
• Bone marrow biopsy revealing adequate hematologic reserves

Exclusion Criteria:

• Evidence of circulating tumor cells >500 cells/microliter of lymphocytes or equivalent
• History of allergic reactions to any component of the study drug
• Autoimmune disease (Exceptions: autoimmune thyroiditis)
• Concomitant use of systemic corticosteroids
• History of seizure disorder
• History of Central Nervous System (CNS) metastases or seizure disorder related to the malignancy.
• History of symptomatic congestive heart failure (CHF), unstable angina pectoris, unstable atrial fibrillation; cardiac arrhythmia
• Non-manageable electrolyte imbalances, including hypokalemia, hypocalcemia, hypomagnesemia, and hypomagnesemia, of Grade 2 or greater (NCI-CTCAE v. 4.0)
• Any uncontrolled intercurrent illness, infection, or other condition that could limit study compliance or interfere with assessments
• Pregnancy or breast feeding