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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGIncidence rate of dose limiting toxicities (DLTs) during the first cycle of treatment (Phase I)
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
Time frame: 28 days
Overall Response Rate (ORR) - Phase I
Preliminary measure of anti-tumor activity of CT-1530
Time frame: Up to 24 month
Progression free survival (PFS) per RECIST v1.1 - Phase I
Preliminary measures of anti-tumor activity of CT-1530
Time frame: Up to 24 months
Duration of response (DOR)
Preliminary measure of anti-tumor activity of CT-707
Time frame: Up to 24 months
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