Safety, Tolerability, and Anti-cancer Activity of KAHR-102 (The Study Drug) for the Treatment of Lymphoma Patients

This is an interventional treatment trial for Lymphoma Read More

Inclusion Criteria:

• Subjects diagnosed with recurrent malignant lymphoma, which express B7 and FasR and have either failed to respond to standard therapy, relapsed and for whom no standard therapy is available.
• Measurable disease as measured by "Lugano" Classification.
• A measurable node must have a longest diameter (LDi) greater than 1.5 cm. Measurable extranodal disease (eg, hepatic nodules) may be included in the six representative, measured lesions. A measurable extranodal lesion should have an LDi greater than 1.0 cm
• Biopsy of tumor stains positive to cluster of differentiation 95 (CD95) and to Cluster of Differentiation 80 (CD80) or Cluster of Differentiation 86 (CD86) or both within the last 6 months.
• If greater than 6 months , a fine-needle aspiration (FNA) should be performed
• Men and Women age > 18.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3.
• Estimated life expectancy of at least 2 months.
• Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase, aspartate aminotransferase ≤2× ULN).
• Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥30 ml/min/1.73m2 as measured by Cockcroft -Gault / CKD (Chronic Kidney Disease)/EPI (Epidemiology Collaboration) formulas.
• Platelet count ≥ 50,000 and an absolute neutrophil count (ANC) ≥ 1500 /mm3.
• Women of child bearing potential practicing an acceptable method of birth control.
• Understanding of study procedures and willingness to comply for the entire length of the study and to give written informed consent.

Exclusion Criteria:

• Other standard anti-neoplastic therapies are available.
• Known Central Nervous System (CNS) lymphoma.
• Chronic lymphocytic leukemia and autoimmunity leukemia.
• Known hypersensitivity to the study drug or to any of its components.
• Chronic heat failure (CHF) New-York heart association (NYHA) = Class IV.
• Known Chronic Obstructive Pulmonary Disease (COPD) > Stage 3 (Forced Expiratory Volume -(FEV1)<50%, FEV1/Forced Vital Capacity (FVC)<70%).
• Chronic kidney disease (CKD) >Stage 4 (subjects with known Filtration rate (FR)<30 milliliter (mL)/min/1.73m2).
• Cirrhosis (Child-Pugh Class C score).
• Known hypersensitivity to drug components.
• Prior chemotherapy within 3 weeks, nitrosureas within 6 weeks, therapeutic anticancer antibodies within 3 weeks, radio or toxin immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 28 days of first dose of the study drug.
• American Society for Cytotechnology (ASCT) and prior allogeneic stem cell transplantation (SCT)< 12 weeks prior to first dose of the study drug.
• Myelosuppressive treatment within 2-3 weeks of entering this study. Prednisone allowed.
• Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study.
• Positive test for acquired immune deficiency syndrome (AIDS).
• Any positive test for hepatitis B or hepatitis C virus (HBV or HCV) indicating acute or chronic infection (HBsAg, HBcAb total and anti-HCV Abs).
• Presence of uncontrolled infection.
• Evidence of active bleeding or bleeding susceptibility or medically significant hemorrhage within prior 30 days.
• Coumadin therapy.
• Pregnant or lactating.
• Treatment with other investigational drugs within 14 days of start of this study.
• Prisoners or subjects who are involuntarily incarcerated.
• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.