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A Study to Evaluate Safety, PK, PD and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With R/R B-Cell Malignancies.

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)

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• AZD5492 (drug)

Sponsor: AstraZeneca · Participants: 174 · Started: Sep 18, 2024

Contact the study team

• AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479

Official record on ClinicalTrials.gov — NCT06542250

Locations in the U.S.

Conditions

• B-Cell Leukemia
• Chronic Lymphocytic Leukemia
• Mantle Cell Lymphoma
• Follicular Lymphoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.