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CD20 Monoclonal Antibody Combined With BTK Inhibitor for the Treatment of Refractory Immune-related Cytopenia

19. maj 2026 opdateret af: Qi deng

Clinical Study on the Treatment of Refractory Immune-related Cytopenia With CD20 Monoclonal Antibody Combined With BTK Inhibitor (BTKi)

This study aims to utilize anti-CD20 monoclonal antibodies to eliminate peripheral B cells and reduce the mechanism of autoantibody production, as well as combine the mechanism of BTK inhibitors (BTKi) blocking the B cell receptor signaling pathway and inhibiting B cell activation and proliferation, for the treatment of refractory immune-related cytopenia. In this study, it includes the salvage treatment of immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), expecting to achieve a synergistic and enhancing effect. This study aims to select Zuberitamab, a human-mouse chimeric anti-CD20 monoclonal antibody, and the BTKi Orelabrutinib as combination therapy options. The clinical efficacy of the Zuberitamab-Orelabrutinib combination therapy (overall response rate, duration of sustained remission) will be evaluated, along with its safety profile (including infections, bleeding, cardiac toxicity), to provide a theoretical basis for their combined use in treating refractory immune-related thrombocytopenia (ITP and AIHA).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Fase 1

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Diagnosed with refractory immune-related cytopenia, including immune thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA);
  • Age ranging from 18 to 80 years old (inclusive of 18 and 80);
  • Expected survival time > 12 months;

  • Good function of major organs:

    1. liver function: ALT/AST < 3 times the upper limit of normal;
    2. kidney function: creatinine < 100 μmol/L;
    3. lung function: indoor oxygen saturation ≥ 95%;
    4. heart function: left ventricular ejection fraction (LVEF) ≥ 50%;
  • Peripheral superficial venous blood flow is unobstructed, capable of meeting the requirements for intravenous infusion;
  • Karnofsky score ≥ 60, ECOG ≤ 2 points.

Exclusion Criteria:

  • Women who are pregnant (with positive urine/blood pregnancy test results) or breastfeeding;

  • Those who have severe underlying heart diseases when participating in this study, including:

    1. clinically significant atrial fibrillation (AF),
    2. cardiac conduction block,
    3. myocardial infarction (within 1 year),
    4. congestive heart failure (CHF);
    5. cardiac echocardiography LVEF < 50%;
    6. New York Heart Association (NYHA) cardiac function classification of III-IV grade;
  • Those with active bleeding or bleeding tendencies, and those who need to take anticoagulant drugs;
  • Those with organ dysfunction or uncontrollable coexisting diseases;
  • History of malignant tumors;
  • Those with active chronic hepatitis B or active hepatitis C;
  • Known history of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome;
  • Those with uncontrollable infectious diseases;
  • As determined by the investigator, other unsuitable conditions exist.

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: Zuberitamab-Orelabrutinib combination therapy
This study is designed as a non-randomized, single-arm, open-label clinical trial. Patients with refractory immune-related cytopenia, including immune thrombocytopenia (ITP) and autoimmune hemolytic anemia (AIHA), are intended for enrollment. The treatment regimen and schedule are as follows: anti-CD20 monoclonal antibody (Zuberitamab): 100 mg per dose on Days 1, 8, 15, and 22; BTK inhibitor (Orelabrutinib): 50 mg once daily (qd) from Day 1 to Day 90.
Medicin: Anti-CD20 monoclonal antibody and the BTK inhibitor
This is a novel combination regimen of anti-CD20 monoclonal antibody plus BTKi, specifically designed for patients with refractory immune-related cytopenia.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the Median overall response rate at 6 months of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
Tidsramme: Six month after treatment initiation
Median overall response rate at 6 months after treatment initiation
Six month after treatment initiation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the early overall response rate 3 months after the start of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
Tidsramme: Three month after therapy
The early overall response rate 3 months after the start of treatment
Three month after therapy
Evaluate the sustained remission rate that lasts for 6 months after achieving remission following anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
Tidsramme: Six month after achieving remission
The sustained remission rate that lasts for 6 months after achieving remission
Six month after achieving remission
Evaluate the Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of anti-CD20 monoclonal antibody and BTKi combination therapy in refractory immune-related cytopenia
Tidsramme: Up to three month after therapy
The incidence and severity of therapy related toxic reactions (including infections, bleeding, cardiac toxicity)
Up to three month after therapy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Qi deng

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 (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. maj 2028

Studieafslutning (Anslået)

31. maj 2028

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026-50

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Immun trombocytopeni (ITP)

Kliniske forsøg med Anti-CD20 monoclonal antibody and the BTK inhibitor

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Mozambique

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner