Overview

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