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RecruitingLast updated: 18 November 2024

TITANium: This clinical trial is evaluating a immunotherapy injection (called AZD5492) in people with relapsed or refractory B-cell malignanciesA 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

TITANium

Clinical summary

Summary

AZD5492 is a T Cell-engaging antibody targeting CD20 which is administered subcutaneously (an injection under the skin). This study is evaluating whether AZD5492 is safe, tolerable, and efficacious in people with the following CD20+ mature B-cell malignancies:

  • Large B-cell lymphoma
  • Follicular lymphoma
  • Mantle cell lymphoma
  • Chronic lymphocytic leukaemia
  • Small lymphocytic lymphoma.

 

Conditions

This trial is treating people with CD20+ B-cell malignancies that are relapsed, progressive and/or refractory following at least 2 prior lines of therapy

Eligibility

Inclusion

  • ≥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.

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

Exclusion

  • Active CNS involvement in lymphoma or CNS pathology;
  • Diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or Burkitt-like lymphoma;
  • 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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

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)

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