- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04103905
A Study of MIL62 in Treatment of CD20 Positive B-cell Lymphomas
15. juni 2021 opdateret af: Beijing Mabworks Biotech Co., Ltd.
A Multi-Center, Open Label, Single Arm, Multiple Dose Study to Assess the Tolerability,Pharmacokinetics and Efficacy of MIL62 in Chinese Patients With Relapsed/Refractory CD20+ Malignant B-cell Lymphomas
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
27
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Beijing
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Beijing, Beijing, Kina, 100021
- Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Adult patients, >=18 years of age;
- Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy >6 months
- Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; 3) dose interruptions; and 4) for at least 2 months after discontinuation of all study treatments
- Able and willing to provide written informed consent and to comply with the study protocol
Exclusion Criteria:
- Prior use of any investigational antibody therapy within 3 months of study start
- Prior use of any anti-cancer vaccine
- Prior administration of radioimmunotherapy 3 months prior to study entry
- Central nervous system lymphoma
- History of other malignancy
- Evidence of significant, uncontrolled concomitant disease
- Abnormal laboratory values
- Patients with progressive multifocalleukoencephalopathy (PML)
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: MIL62
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of Participants Who Experienced a Dose-limiting Toxicity in Dose Escalation Period of the Study
Tidsramme: Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period
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Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percentage of Participants With Best Overall Response
Tidsramme: by the end of Cycle 8 (each cycle is 28 days)
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by the end of Cycle 8 (each cycle is 28 days)
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Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
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by the end of Cycle 4 (each cycle is 28 days)
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Area Under the Plasma Concentration Versus Time Curve (AUC) of MIL62 Under Steady State
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
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by the end of Cycle 4 (each cycle is 28 days)
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Systemic Clearance of MIL62 Under Steady State
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
|
by the end of Cycle 4 (each cycle is 28 days)
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Volume of Distribution Under Steady State (Vss) of MIL62
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
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by the end of Cycle 4 (each cycle is 28 days)
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Terminal Plasma Half-Life (t1/2) of MIL62 Under Steady State
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
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by the end of Cycle 4 (each cycle is 28 days)
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Change in Cluster of Differentiation 19 (CD19+) B Cells
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
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by the end of Cycle 4 (each cycle is 28 days)
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Change in Cluster of Differentiation 20 (CD20+) B Cells
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
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by the end of Cycle 4 (each cycle is 28 days)
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Percentage of Participants with Positive Anti-Drug Antibodies to MIL62
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
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by the end of Cycle 4 (each cycle is 28 days)
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Progression-free Survival (PFS) in the Study
Tidsramme: by the end of the follow-up period of the study
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by the end of the follow-up period of the study
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Overall Survival (OS) in the Study
Tidsramme: by the end of the follow-up period of the study
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by the end of the follow-up period of the study
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Duration of response (DoR)
Tidsramme: by the end of the follow-up period of the study
|
by the end of the follow-up period of the study
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Disease control rate (DCR)
Tidsramme: by the end of the follow-up period of the study
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by the end of the follow-up period of the study
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Participants With Event-Free Survival (EFS)
Tidsramme: by the end of the follow-up period of the study
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by the end of the follow-up period of the study
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Yuankai Shi, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
10. februar 2017
Primær færdiggørelse (Faktiske)
30. maj 2019
Studieafslutning (Faktiske)
29. maj 2020
Datoer for studieregistrering
Først indsendt
18. september 2019
Først indsendt, der opfyldte QC-kriterier
24. september 2019
Først opslået (Faktiske)
26. september 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2021
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MIL62-CT01
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