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Evaluating a new T cell-engaging antibody for B-cell cancers

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)

Phase1; Phase2 Interventional AstraZeneca · NCT06542250

This study is testing a new antibody treatment for people with tough-to-treat B-cell cancers to see if it is safe and effective after they have already tried other therapies.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment174 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Locations30 sites (La Jolla, California and 29 other locations)
Trial IDNCT06542250 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety, pharmacokinetics, pharmacodynamics, and efficacy of AZD5492, a T cell-engaging antibody that targets CD20, in patients with relapsed or refractory B-cell malignancies. Participants will receive the experimental treatment to determine its tolerability and effectiveness after having undergone at least two prior lines of therapy. The study will include various types of B-cell neoplasms, such as large B-cell lymphoma and chronic lymphocytic leukemia, and will monitor participants for adverse effects and treatment outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed CD20+ B-cell neoplasms who have relapsed or refractory disease after previous treatments.

Not a fit: Patients with neoplasms not specified in the inclusion criteria or those with active CNS involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have performed: Other studies targeting CD20 with T cell-engaging therapies have shown promise, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

La Jolla, California and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions B-cell MalignanciesCD20CD8T cell engagerTCRAZD5492Relapsed, RefractoryB-cell malignancies
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.