Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).

The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).

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

Details

• Lead Sponsor: Centaurus Biopharma Co., Ltd.

Criteria

Inclusion Criteria:

• Confirmed diagnosis of B cell Non-Hodgkin Lymphoma(according to World Health Organization [WHO] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop).

• Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment.

• Eastern Cooperative Oncology Group performance status of ≤ 1 and a life expectancy of at least 3 months.

• Measurable disease as per RECIST v1.1

• Availability of tumor sample

• Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10^9/L and platelets ≥ 50 x 10^9/L; patients with neutrophils < 1.0 x 10^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10^9/L.

• Adequate renal function, as defined by creatinine clearance of ≥ 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).

• Adequate liver function, as defined by AST and ALT ≤ 3 x ULN, and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome).

Exclusion Criteria:

• Prior allogeneic bone marrow transplant

• Autologous stem cell transplant within 3 months of screening

• Active central nervous system involvement

• Subjects with autoimmune hemolytic anemia or immune thrombocytopenia

• Prior treatment with a Btk inhibitor

• Active uncontrolled infection

• History of malabsorption

• Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc.

• History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months

• History of another currently active cancer

• History of major surgery within 4 weeks or minor surgery within 1 week

• Other medical or psychiatric illness or organ dysfunction

• HIV positive

• Positive for Hepatitis B surface antigen or Hepatitis C-virus

Other protocol-defined inclusion/exclusion criteria may apply