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Monoclonal Antibodies

AZD0486 for B-Cell Lymphoma

Phase 2

Waitlist Available

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 0 to 2

Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min

Must not have

History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to be assessed up to approximately 5 years

Awards & highlights

Summary

This trial is testing a new drug called AZD0486 in adults with relapsed or refractory B-cell non-Hodgkin lymphoma. Participants must have already tried at least two other treatments

Who is the study for?

This trial is for adults with B-cell non-Hodgkin lymphoma (NHL) who have tried at least two other treatments without success. It's specifically aimed at those with certain types of NHL, like Follicular Lymphoma and Diffuse Large B-Cell Lymphoma.

What is being tested?

The study is testing AZD0486 as a single treatment option. Participants are divided into two groups based on their type of NHL: one group for Follicular Lymphoma (Module 1) and another for Diffuse Large B-Cell Lymphoma (Module 2).

What are the potential side effects?

While the specific side effects of AZD0486 aren't listed here, common side effects from similar cancer treatments include nausea, fatigue, fever, infections due to low blood cell counts, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most activities by myself.

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My kidneys are functioning well, with a creatinine clearance rate of 45 mL/min or higher.

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I am between 18 and 80 years old.

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I have a cancerous lesion that is visible and measurable on scans.

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My FL or DLBCL has not responded to at least 2 previous treatments.

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My lymphoma cells are CD-19 positive after my last CD-19 targeted treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have significant brain-related health issues like epilepsy, stroke, or dementia.

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I have been diagnosed with CLL, Burkitt lymphoma, or Richter's transformation.

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My brain or spinal cord is affected by non-Hodgkin lymphoma.

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My B-cell non-Hodgkin lymphoma is showing up in my blood.

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I haven't had T-cell, CAR T-cell therapy, or stem cell transplants recently.

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I am on long-term medication to suppress my immune system.

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I have no ongoing major side effects from previous treatments.

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I have a history of serious heart problems.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to be assessed up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to be assessed up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and to be assessed up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in EORTC IL233 scales

Change from baseline in FACT-LymS scales

Change from baseline in IL232 QL2 score

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCLExperimental Treatment1 Intervention

In Module 2, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R DLBCL. AZD0486 will be administered as intravenous infusion.

Group II: Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular LymphomaExperimental Treatment1 Intervention

In Module 1, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R FL. AZD0486 will be administered as intravenous infusion.

0 / 15Eligibility criteria met

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,352 Previous Clinical Trials

288,646,569 Total Patients Enrolled

~160 spots leftby Feb 2027

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