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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 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.

NCT06542250

RecruitingPhase 1, Phase 2

Sponsor: AstraZeneca

Conditions: B-cell Malignancies

Interventions: AZD5492

Countries: United States, Australia, Canada, China, Denmark, France, Germany, Italy

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.
Locations (31)
  • La Jolla, California, United States
  • Boston, Massachusetts, United States
  • Rochester, Minnesota, United States
  • Hackensack, New Jersey, United States
  • New York, New York, United States
  • New York, New York, United States
  • Charlotte, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Houston, Texas, United States
  • Seattle, Washington, United States
  • Melbourne, Australia
  • Nedlands, Australia
  • Calgary, Alberta, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Hangzhou, China
  • Shanghai, China
  • København Ø, Denmark
  • Pessac, France
  • Villejuif, France
  • Göttingen, Germany
  • München, Germany
  • Ulm, Germany
  • Würzburg, Germany
  • Bologna, Italy
  • Milan, Italy
  • Chūōku, Japan
  • Kashiwa, Japan
  • Barcelona, Spain
  • L'Hospitalet de Llobregat, Spain
  • + 1 more on CT.gov