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

Sponsor

Centaurus Biopharma Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02981745

Collaborator

(none)

200

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma Chronic Lymphocytic Leukemia Waldenstrom's Macroglobulinemia Mantle Zone Lymphoma Refractory/Recurrent Follicle Centre Lymphoma Diffuse Diffuse Large B Cell Lymphoma	Drug: CT-1530	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT-1530	Drug: CT-1530 Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma

Arm

Intervention/Treatment

Experimental: CT-1530

Drug: CT-1530

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma

Outcome Measures

Primary Outcome Measures

Incidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I) [28 days]
Maximum Tolerated Dose(s) (MTD(s)) and/or recommended phase 2 dose (RP2D(s)) of CT-1530 in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Mental-cell lymphoma, Diffuse large B-cell lymphoma, FL and Waldenstrom's Macroglobulinemia

Secondary Outcome Measures

Overall Response Rate (ORR) - Phase I [Up to 24 month]
Preliminary measure of anti-tumor activity of CT-1530
Progression free survival (PFS) per RECIST v1.1 - Phase I [Up to 24 months]
Preliminary measures of anti-tumor activity of CT-1530
Duration of response (DOR) [Up to 24 months]
Preliminary measure of anti-tumor activity of CT-707

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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