This is a Phase I/II, single arm, multi-center, open-label clinical trial of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy) and who are indicated for treatment per IWCLL2018.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
13
MS-553
Peking University People's Hospital
Beijing, Xicheng District, China
Incidence of dose limiting toxicities
Time frame: 28 days
Incidence and severity of adverse events
Time frame: Assessed throughout the study from the time of first dose of study drug until 30 days after the patient's last dose of study drug or until the event has resolved, stabilized, or an outcome reached, whichever comes first regardless of timing of EoT visit
Overall response rate
Time frame: up to 24 months
Time to tumor response
Time frame: During intervention
Disease control rate
Time frame: During intervention
Progression free survival
Time frame: During intervention
Overall survival
Time frame: During intervention
Assessment of minimal residual disease
Time frame: During intervention
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