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Monoclonal Antibodies
AZD5492 for B-Cell Lymphoma (TITANium Trial)
Phase 1 & 2
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of ≤ 2
≥18 years of age
Must not have
Active CNS involvement in lymphoma or CNS pathology
Prior allogeneic HSCT within 180 days, prior autologous HSCT within 90 days, or cell therapy within 90 days of start of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up module 1 - from first dose of azd5492 up to approximately 2 years.
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new treatment called AZD5492 to see if it is safe and effective for people with B-cell cancers that have not responded to other treatments."
Who is the study for?
This trial is for individuals with B-Cell Malignancies that have not responded to or have returned after previous treatments. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a particular stage or type of disease.
What is being tested?
The study is testing AZD5492, an experimental T cell-engaging antibody targeting CD20. It's in early stages (Phase I/II) to see if it's safe, tolerable, and effective for treating Relapsed or Refractory B-Cell Malignancies.
What are the potential side effects?
Potential side effects are not listed; however, as with many cancer therapies, they could include immune system reactions, infusion-related responses, fatigue, nausea and potential impact on blood counts leading to increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can do most of my daily activities on my own.
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I am 18 years old or older.
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My condition worsened after two previous treatments.
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My cancer is a type of B-cell lymphoma or leukemia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lymphoma affects my brain or spinal cord.
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I haven't had a stem cell transplant or cell therapy in the last 3 to 6 months.
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I have been diagnosed with a specific type of lymphoma.
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I have had severe reactions to previous treatments.
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I do not have any ongoing and untreated infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ module 1 - from first dose of azd5492 up to approximately 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~module 1 - from first dose of azd5492 up to approximately 2 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequency of dose limiting toxicities (DLTs).
Safety evaluation of AZD5492: Number of participants with treatment-related adverse events.
Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events.
Secondary study objectives
Complete Response Rate (CR Rate)
Duration of Response (DoR)
Overall Response Rate (ORR)
+8 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Module 1: AZD5492 MonotherapyExperimental Treatment1 Intervention
AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,425 Previous Clinical Trials
289,140,770 Total Patients Enrolled
55 Trials studying Lymphoma
7,761 Patients Enrolled for Lymphoma