Monoclonal Antibodies

Odronextamab for Large B-Cell Lymphoma

Seattle, WA

Phase 2

Waitlist Available

Led By Mengyang Di, MD, PhD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed large B cell lymphoma, including various subtypes

Eastern Cooperative Oncology Group performance status of 0-1 (or 2 if attributed to lymphoma)

Must not have

Allogeneic stem cell transplantation

Detectable cerebrospinal fluid malignant cells or brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a medication called odronextamab, which is given before CAR-T cell therapy, in patients with large B-cell lymphomas that have not responded to previous treatment. Odron

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Who is the study for?

This trial is for patients with large B-cell lymphomas that have either relapsed or are refractory. Candidates should be planning to receive CAR-T cell therapy and need a treatment option to control their disease before undergoing leukapheresis.Check my eligibility

What is being tested?

The trial is testing odronextamab as a 'bridging therapy' before CAR-T cell therapy in patients with certain types of B-cell lymphoma. The goal is to see if it can prevent cancer progression and improve the success rate of subsequent CAR-T treatment.See study design

What are the potential side effects?

Potential side effects include reactions related to the immune system, such as fever, fatigue, and infusion-related symptoms due to odronextamab's dual targeting of T-cells and tumor-associated antigens.

Eligibility Criteria

Inclusion Criteria

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

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My diagnosis is large B cell lymphoma.

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I am fully active or have some symptoms but can still do light work.

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My first treatment for large B cell lymphoma did not work.

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I am 18 years old or older.

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I have been treated with anti-CD20 antibody therapy before.

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Exclusion Criteria

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

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I have received a stem cell transplant from a donor.

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My cancer has spread to my brain or spinal fluid.

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I have recently undergone chemotherapy or radiotherapy.

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I have previously received CAR-T cell therapy.

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I have recently been treated with targeted therapy drugs.

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I am currently being treated for another cancer.

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I do not have any infections that aren't responding to treatment.

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I am taking high doses of corticosteroids.

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I have a specific viral infection or chronic hepatitis.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Failure to undergo leukapheresis

Secondary study objectives

CR rate

Incidence of AEs

Overall response rate (ORR) following bridging prior to CAR-T infusion

+3 more

Awards & 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: Treatment (odronextamab)Experimental Treatment11 Interventions

Patients receive odronextamab IV based on the following schedules: * Step-up dosing during cycle 1: 0.2 mg on C1D1, 0.5 mg on C1D2, 2 mg on C1D8 and C1D9, respectively, and 10 mg on C1D15 and C1D16, respectively (0.7/4/20 regimen). * Dosing during cycles 2-4: Odron will be given at 160 mg weekly. * Once every other week at 320 mg of remaining cycles. Please see the Detailed Description for additional information.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2440

Leukapheresis

2016

Completed Phase 2

~710