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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIL62 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Humanized Monoclonal Antibody MIL62 Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study | Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Best Overall Response | by the end of Cycle 8 (each cycle is 28 days) | |
| Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62 | by the end of Cycle 4 (each cycle is 28 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi | Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC) | Beijing | Beijing Municipality | 100021 | China |
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| Area Under the Plasma Concentration Versus Time Curve (AUC) of MIL62 Under Steady State | by the end of Cycle 4 (each cycle is 28 days) |
| Systemic Clearance of MIL62 Under Steady State | by the end of Cycle 4 (each cycle is 28 days) |
| Volume of Distribution Under Steady State (Vss) of MIL62 | by the end of Cycle 4 (each cycle is 28 days) |
| Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State | by the end of Cycle 4 (each cycle is 28 days) |
| Change in Cluster of Differentiation 19 (CD19+) B Cells | by the end of Cycle 4 (each cycle is 28 days) |
| Change in Cluster of Differentiation 20 (CD20+) B Cells | by the end of Cycle 4 (each cycle is 28 days) |
| Percentage of Participants with Positive Anti-Drug Antibodies to MIL62 | by the end of Cycle 4 (each cycle is 28 days) |
| Progression-free Survival (PFS) in the Study | by the end of the follow-up period of the study |
| Overall Survival (OS) in the Study | by the end of the follow-up period of the study |
| Duration of response (DoR) | by the end of the follow-up period of the study |
| Disease control rate (DCR) | by the end of the follow-up period of the study |
| Participants With Event-Free Survival (EFS) | by the end of the follow-up period of the study |