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

• Status: Withdrawn
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and to determine the Dose Limiting Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kahr Medical

Criteria

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.