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RecruitingInterventionalPhase 1/Phase 2

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)

NCT ID: NCT06542250Sponsor: AstraZenecaLast updated: 2026-05-01

Summary

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.

Arms & interventions

  • DrugAZD5492

    CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously

Outcome measures

Primary

  • Frequency of dose limiting toxicities (DLTs).

    DLTs are dose-limiting toxicities as defined in the study protocol.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

Secondary

  • Overall Response Rate (ORR)

    Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.

  • Complete Response Rate (CR Rate)

    Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.

  • Duration of Response (DoR)

    Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.

  • Progression-free Survival (PFS)

    Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.

  • Overall Survival (OS)

    Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.

  • Pharmacokinetics of AZD5492: serum concentration of study drug

    Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.

  • Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax).

    Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.

  • Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC).

    Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.

  • Pharmacokinetics of AZD5492: apparent clearance

    Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.

  • Pharmacokinetics of AZD5492: Half-life (t 1/2)

    Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.

  • To determine the immunogenicity of AZD5492

    Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.

  • To determine the immunogenicity of AZD5492

    Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * ≥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. Exclusion Criteria: * 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.

Study locations (10)

Research Site

La Jolla, California, 92093

Recruiting

Research Site

Boston, Massachusetts, 02215

Withdrawn

Research Site

Rochester, Minnesota, 55905

Not Yet Recruiting

Research Site

Hackensack, New Jersey, 07601

Recruiting

Research Site

New York, New York, 10021

Recruiting

Research Site

New York, New York, 10029

Recruiting

Research Site

Charlotte, North Carolina, 28203

Recruiting

Research Site

Winston-Salem, North Carolina, 27157

Recruiting

Research Site

Houston, Texas, 77030

Recruiting

Research Site

Seattle, Washington, 98109

Recruiting