This open-label, multicenter,dose-escalating phase I study was designed to evaluate the safety, tolerability, pharmacokinetics and efficacy of MIL62 in Chinese patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma(NHL) for whom no treatment of higher priority was available.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The patients confirming to the eligibility criteria will be assigned to the 5 dose groups (200mg, 400mg, 800mg, 1000mg, and 1500mg, respectively) based on the sequence of inclusion. Each patient received an intravenous infusion of MIL62 on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 10 infusions. Each cycle was 21 days.
Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, China
Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study
Time frame: Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period
Percentage of Participants With Best Overall Response
Time frame: by the end of Cycle 8 (each cycle is 28 days)
Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62
Time frame: by the end of Cycle 4 (each cycle is 28 days)
Area Under the Plasma Concentration Versus Time Curve (AUC) of MIL62 Under Steady State
Time frame: by the end of Cycle 4 (each cycle is 28 days)
Systemic Clearance of MIL62 Under Steady State
Time frame: by the end of Cycle 4 (each cycle is 28 days)
Volume of Distribution Under Steady State (Vss) of MIL62
Time frame: by the end of Cycle 4 (each cycle is 28 days)
Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State
Time frame: by the end of Cycle 4 (each cycle is 28 days)
Change in Cluster of Differentiation 19 (CD19+) B Cells
Time frame: by the end of Cycle 4 (each cycle is 28 days)
Change in Cluster of Differentiation 20 (CD20+) B Cells
Time frame: by the end of Cycle 4 (each cycle is 28 days)
Percentage of Participants with Positive Anti-Drug Antibodies to MIL62
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: by the end of Cycle 4 (each cycle is 28 days)
Progression-free Survival (PFS) in the Study
Time frame: by the end of the follow-up period of the study
Overall Survival (OS) in the Study
Time frame: by the end of the follow-up period of the study
Duration of response (DoR)
Time frame: by the end of the follow-up period of the study
Disease control rate (DCR)
Time frame: by the end of the follow-up period of the study
Participants With Event-Free Survival (EFS)
Time frame: by the end of the follow-up period of the study