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.

Recruiting now · Phase 1/Phase 2

Conditions studied: B-cell Malignancies

In brief

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.

Key facts

Study ID

NCT06542250

Run by

AstraZeneca

People needed

174

Starts

2024-09-18

Expected to finish

2029-12-18

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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.

You may not qualify if…

• 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 it is running

• Research Site — Madrid, Spain (enrolling)
• Research Site — L'Hospitalet de Llobregat, Spain (enrolling)
• Research Site — La Jolla, California, United States (enrolling)
• Research Site — Rochester, Minnesota, United States (enrolling)
• Research Site — Hackensack, New Jersey, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Charlotte, North Carolina, United States (enrolling)
• Research Site — Winston-Salem, North Carolina, United States (enrolling)
• Research Site — Houston, Texas, United States (enrolling)
• Research Site — Seattle, Washington, United States (enrolling)
• Research Site — Melbourne, Australia (enrolling)
• Research Site — Nedlands, Australia (enrolling)
• Research Site — Calgary, Alberta, Canada (enrolling)
• Research Site — Toronto, Ontario, Canada (enrolling)
• Research Site — Montreal, Quebec, Canada (enrolling)
• Research Site — Hangzhou, China (enrolling)
• Research Site — Shanghai, China (enrolling)
• Research Site — København Ø, Denmark (enrolling)
• Research Site — Pessac, France (enrolling)
• Research Site — Villejuif, France (enrolling)
• Research Site — München, Germany (enrolling)
• Research Site — Ulm, Germany (enrolling)
• Research Site — Würzburg, Germany (enrolling)
• Research Site — Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

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