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CAR T-cell Therapy

Epcoritamab + Lenalidomide for B-Cell Lymphoma

Chicago, IL

Phase 2

Waitlist Available

Led By Reem Karmali, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Patients with a known history of chronic hepatitis B virus (HBV) infection must have undetectable viral load on suppressive therapy

Patients must have no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

Must not have

Patients who have received specific prior therapies

Patients with evidence of active disease in the central nervous system (CNS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the initiation of trial therapy until: the response has been confirmed, the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation. this will be assessed at 3, 6, 12, 18, and 24 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial combines two drugs, epcoritamab and lenalidomide, to see how well they work in treating a specific type of lymphoma that has not responded to treatment or

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Who is the study for?

This trial is for patients with immunodeficiency-related large B-cell lymphoma that has either not responded to previous treatments or has returned after treatment. Participants should have a type of non-Hodgkin's lymphoma and be in a relapsed or refractory state.Check my eligibility

What is being tested?

The trial is testing the effectiveness of combining two drugs, Epcoritamab and Lenalidomide, on treating this specific lymphoma. Epcoritamab helps direct the immune system's T-cells to attack cancer cells, while Lenalidomide boosts the immune response against these cells.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as fever, fatigue, and infusion-related reactions from Epcoritamab. Lenalidomide can cause blood clots, rash, and may impact blood cell counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I have chronic hepatitis B but it's under control with treatment.

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I do not currently have an active COVID-19 infection.

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My diagnosis is immunodeficiency-related large B-cell lymphoma.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I had hepatitis C but am now cured or have no detectable virus while on treatment.

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I am 18 years old or older.

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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 specific treatments before.

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I have active cancer in my brain or spinal cord.

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I do not have uncontrolled seizures, recent major surgery, serious heart issues, trouble swallowing pills, or recent live vaccines.

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I am not pregnant or nursing.

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I had a stem cell transplant using my own cells within the last 100 days.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the initiation of trial therapy until: the response has been confirmed, the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation. this will be assessed at 3, 6, 12, 18, and 24 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the initiation of trial therapy until: the response has been confirmed, the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation. this will be assessed at 3, 6, 12, 18, and 24 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the initiation of trial therapy until: the response has been confirmed, the subject experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation. this will be assessed at 3, 6, 12, 18, and 24 months. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Best response of complete response (CR) rate

Secondary study objectives

Duration of response (DOR)

Incidence of adverse events

Objective response rate (ORR)

+2 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 (epcoritamab, lenalidomide)Experimental Treatment6 Interventions

Patients receive epcoritamab SC weekly during cycle 1 and on days 1, 8, 15, and 22 of cycles 2-3, and day 1 of cycles 4-12. Patients also receive lenalidomide PO on days 1-21 of each cycle. Cycles repeat every 28 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT and collection of blood samples throughout the study and may undergo MRI during screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~1810

Computed Tomography

2017

Completed Phase 2

~2440