Acute Lymphoblastic Leukemia Clinical Trial
Official title:
An Open-label, Multi-center Phase Ib/II Study of CN201 in Subjects With Precursor B-cell Acute Lymphoblastic Leukemia
An effective treatment for adults and children B-ALL represents a significant unmet need. CN201 has demonstrated efficacy in nonclinical models of leukemia .CN201 has a longer half-life, thus long term continuous intravenous infusion is not necessary for clinical use. The present study will be conducted in 2 parts: Phase Ib is a dose finding phase to identify the RP2D. Phase II will allow further evaluation of the safety and efficacy of CN201 at the RP2D.
This is a multicenter, open-label, Phase Ib/II study in subjects with precursor B-cell acute lymphoblastic leukemia (B-ALL). This study is designed in 2 parts as described below: Phase Ib (dose escalation and expansion) and Phase II. If in Phase Ib it is observed in adult subjects at doses with manageable risk and antitumor activity, studies in pediatric subjects can be initiated to explore safety and efficacy in pediatric subjects, as well as pharmacokinetic profiles. For Phase Ib, the dose escalation employs Bayesian optimal interval (BOIN) design. Administered by IV infusion, once every week (QW), will be evaluated to determine the MTD and/or RP2D of CN201. After RP2D is determined in Phase Ib, the Phase II study will be initiated to further evaluate the safety, tolerance, PK and PD characteristics, and anti-tumor activity of CN201 in subjects with B-ALL. Simon's two-stage minimax design will be employed to preliminarily explore the efficacy of CN201 in treatment of R/R B-ALL. ;
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