Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

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

    • Beijing
      • Beijing, Beijing, Kina, 100021
        • Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

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:

  1. Adult patients, >=18 years of age;
  2. Diagnosis of Refractory/relapsed CD20+ B-cell lymphoma or B-CLL
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Life expectancy >6 months
  5. 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
  6. Able and willing to provide written informed consent and to comply with the study protocol

Exclusion Criteria:

  1. Prior use of any investigational antibody therapy within 3 months of study start
  2. Prior use of any anti-cancer vaccine
  3. Prior administration of radioimmunotherapy 3 months prior to study entry
  4. Central nervous system lymphoma
  5. History of other malignancy
  6. Evidence of significant, uncontrolled concomitant disease
  7. Abnormal laboratory values
  8. Patients with progressive multifocalleukoencephalopathy (PML)
  9. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DAN or HCV RNA )
  10. 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
Eksperimentel: MIL62
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
Baseline to 28 days after the first infusion of MIL62 of the last participant in dose escalation period

Sekundære resultatmål

Resultatmål
Tidsramme
Percentage of Participants With Best Overall Response
Tidsramme: by the end of Cycle 8 (each cycle is 28 days)
by the end of Cycle 8 (each cycle is 28 days)
Maximum Observed Plasma Concentration (Cmax) Under Steady State of MIL62
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
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
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
by the end of Cycle 4 (each cycle is 28 days)
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)
Volume of Distribution Under Steady State (Vss) of MIL62
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
by the end of Cycle 4 (each cycle is 28 days)
Terminal Plasma Half-Life (t1/2) 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)
Change in Cluster of Differentiation 19 (CD19+) B Cells
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
by the end of Cycle 4 (each cycle is 28 days)
Change in Cluster of Differentiation 20 (CD20+) B Cells
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
by the end of Cycle 4 (each cycle is 28 days)
Percentage of Participants with Positive Anti-Drug Antibodies to MIL62
Tidsramme: by the end of Cycle 4 (each cycle is 28 days)
by the end of Cycle 4 (each cycle is 28 days)
Progression-free Survival (PFS) in the Study
Tidsramme: by the end of the follow-up period of the study
by the end of the follow-up period of the study
Overall Survival (OS) in the Study
Tidsramme: by the end of the follow-up period of the study
by the end of the follow-up period of the study
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
Disease control rate (DCR)
Tidsramme: by the end of the follow-up period of the study
by the end of the follow-up period of the study
Participants With Event-Free Survival (EFS)
Tidsramme: by the end of the follow-up period of the study
by the end of the follow-up period of the study

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med CD20-positive B Cell Non-Hodgkin Lymphoma

3
Abonner