RecruitingPhase 1Phase 2NCT06542250

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)

Sponsor

AstraZeneca

Enrollment

174 participants

Start Date

Sep 18, 2024

Study Type

INTERVENTIONAL

Conditions

B-cell Malignancies

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing AZD5492, a new type of immunotherapy drug called a T-cell engaging antibody, which attaches to both cancer cells (via CD20) and the patient's own T immune cells, helping the immune system destroy lymphoma cells. It is being tested in people with various types of B-cell blood cancers that have come back after at least 2 prior treatments. **You may be eligible if...** - You are 18 or older - You have a CD20-positive B-cell cancer (such as diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, CLL, or SLL) - Your cancer has relapsed or not responded after at least 2 prior lines of treatment - You are reasonably functional (ECOG ≤ 2) **You may NOT be eligible if...** - Your lymphoma type is not among the eligible histologies - You have active lymphoma involvement in the brain or spinal cord - You have a history of seizures or other CNS conditions - You had an allogeneic stem cell transplant within the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAZD5492

CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously

Locations(30)

Research Site

La Jolla, California, United States

Research Site

Boston, Massachusetts, United States

Research Site

Rochester, Minnesota, United States

Research Site

Hackensack, New Jersey, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Charlotte, North Carolina, United States

Research Site

Winston-Salem, North Carolina, United States

Research Site

Houston, Texas, United States

Research Site

Seattle, Washington, United States

Research Site

Melbourne, Australia

Research Site

Nedlands, Australia

Research Site

Calgary, Alberta, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Montreal, Quebec, Canada

Research Site

Hangzhou, China

Research Site

Shanghai, China

Research Site

København Ø, Denmark

Research Site

Pessac, France

Research Site

Villejuif, France

Research Site

München, Germany

Research Site

Ulm, Germany

Research Site

Würzburg, Germany

Research Site

Bologna, Italy

Research Site

Milan, Italy

Research Site

Chūōku, Japan

Research Site

Kashiwa, Japan

Research Site

Barcelona, Spain

Research Site

L'Hospitalet de Llobregat, Spain

Research Site

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT06542250

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