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Die klinische Studie NCT06542250 (TITANium) für B-Zell-Malignome ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen.
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Eine studie zur bewertung von sicherheit, pk, pd und wirksamkeit von azd5492, einem t-zell-aktivierenden antikörper gegen cd20 bei patienten mit r/r b-zell-malignomen (TITANium) Phase 1, Phase 2 174

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Die klinische Studie NCT06542250 (TITANium) untersucht Behandlung im Zusammenhang mit B-Zell-Malignome. Diese interventionsstudie der Phase 1 Phase 2 hat den Status offene rekrutierung und startete am 18. September 2024. Es ist geplant, 174 Teilnehmer aufzunehmen. Durchgeführt von AstraZeneca wird der Abschluss für 14. Februar 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 27. März 2026 aktualisiert.
Kurzbeschreibung
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
Offizieller Titel

A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies (TITANium)

Erkrankungen
B-Zell-Malignome
Weitere Studien-IDs
  • TITANium
  • D9960C00001
NCT-Nummer
NCT06542250
Studienbeginn (tatsächlich)
2024-09-18
Zuletzt aktualisiert
2026-03-27
Studienende (vorauss.)
2028-02-14
Geplante Rekrutierung
174
Studientyp
Interventionsstudie
PHASE
Phase 1
Phase 2
Status
Offene Rekrutierung
Stichwörter
CD20
CD8
T cell engager
TCR
AZD5492
Relapsed, Refractory
B-cell malignancies
CLL, Chronic lymphocytic leukemia
SLL, Small lymphocytic lymphoma
MCL, Mantle cell lymphoma
LBCL, Large B-cell lymphoma
FL, Follicular lymphoma
TITANium
TCE
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Sequentiell
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellModule 1: AZD5492 Monotherapy
AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.
AZD5492
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Frequency of dose limiting toxicities (DLTs).
DLTs are dose-limiting toxicities as defined in the study protocol.
Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).
Safety evaluation of AZD5492: Number of participants with treatment-related adverse events.
Incidence and severity of AEs, AESIs, and SAEs
Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events.
SAEs/AEs leading to discontinuation of AZD5492.
Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Overall Response Rate (ORR)
The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Complete Response Rate (CR Rate)
The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Duration of Response (DoR)
The time from the date of first documented response until the date of documented progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Progression-free Survival (PFS)
The time from the date of first dose until the date of documented disease progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Overall Survival (OS)
The time from the date of first dose until date of death due to any cause.
Module 1 - From first dose of AZD5492 up to 2 years after last dose.
Pharmacokinetics of AZD5492: serum concentration of study drug
Maximum observed serum concentration of AZD5492.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax).
Maximum observed plasma concentration of AZD5492.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC).
Area under the plasma concentration-time curve.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: apparent clearance
The volume of plasma from which the study drug is completely removed per unit time.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Pharmacokinetics of AZD5492: Half-life (t 1/2)
Terminal elimination half-life.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The number of participants who develop ADAs measured in serum.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
To determine the immunogenicity of AZD5492
The percentage of participants who develop ADAs measured in serum.
Module 1 - From informed consent until 90 days after last dose of AZD5492.
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle

  • ≥18 years of age;

  • Histologically documented CD20+ mature B-cell neoplasm

    • Large B-cell lymphoma
    • Follicular lymphoma
    • Mantle cell lymphoma
    • Chronic lymphocytic leukemia
    • Small lymphocytic lymphoma

  • Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;

  • ECOG performance status of ≤ 2 (< 2 in EU countries).

The above is a summary, other inclusion criteria details may apply.

  • Any neoplasm histology not specified in the IC section;
  • Active CNS involvement in lymphoma;
  • CNS pathology including but not limited to any history of seizure disorder/epilepsy;
  • Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy;
  • History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS;
  • Active and uncontrolled infections;
  • Unresolved AEs ≥2 Grade due to prior anticancer therapies, with some exceptions

The above is a summary, other exclusion criteria details may apply.

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Zentrale Studienkontakte
Kontakt: AstraZeneca Clinical Study Information Center, 1-877-240-9479, [email protected]
29 Studienstandorte in 10 Ländern
Research Site, München, 81675, Germany
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Research Site, Ulm, 89081, Germany
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Research Site, Würzburg, 97080, Germany
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California

Research Site, La Jolla, California, 92093, United States
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Massachusetts

Research Site, Boston, Massachusetts, 02215, United States
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New Jersey

Research Site, Hackensack, New Jersey, 07601, United States
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New York

Research Site, New York, New York, 10021, United States
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Research Site, New York, New York, 10029, United States
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North Carolina

Research Site, Charlotte, North Carolina, 28203, United States
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Research Site, Winston-Salem, North Carolina, 27157, United States
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Texas

Research Site, Houston, Texas, 77030, United States
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Washington

Research Site, Seattle, Washington, 98109, United States
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Research Site, Melbourne, 3000, Australia
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Research Site, Nedlands, 6009, Australia
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Alberta

Research Site, Calgary, Alberta, T2N 5G2, Canada
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Ontario

Research Site, Toronto, Ontario, M5G 2M9, Canada
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Quebec

Research Site, Montreal, Quebec, H3T 1R2, Canada
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Research Site, Hangzhou, 310003, China
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Research Site, Shanghai, 200025, China
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Research Site, København Ø, 2100, Denmark
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Research Site, Pessac, 33604, France
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Research Site, Villejuif, 94805, France
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Research Site, Bologna, 40138, Italy
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Research Site, Milan, 20133, Italy
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Research Site, Chūōku, 104-0045, Japan
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Research Site, Kashiwa, 277-8577, Japan
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Research Site, Barcelona, 08035, Spain
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Research Site, L'Hospitalet de Llobregat, 08908, Spain
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Research Site, Madrid, 28040, Spain
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