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Monoclonal Antibodies

Axatilimab + ECP for Graft-versus-Host Disease

Phase 2

Waitlist Available

Led By Trent P Wang, DO

Research Sponsored by University of Miami

Eligibility Criteria Checklist

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

Must have

Age greater or equal to 12

Eastern Cooperative Oncology Group (ECOG) performance status 0-3 as assessed at Screening

Must not have

Patients with aphakia due to risk of increased retinal damage or photosensitive disease (albinism, systemic lupus erythematosus, porphyria)

Active relapse of underlying malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 24 weeks, 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a combination treatment of Axatilimab and Extracorporeal Photopheresis (ECP) is helpful in treating chronic Graft-versus-Host Disease (c

Who is the study for?

This trial is for individuals with chronic Graft-versus-Host Disease (cGVHD), which can affect the skin and lungs after a stem cell or bone marrow transplant. Participants should have specific forms of cGVHD like skin disease or lung complications known as Bronchiolitis Obliterans Syndrome.

What is being tested?

The study is testing the effectiveness of combining Axatilimab, a medication that targets immune cells, with Extracorporeal Photopheresis (ECP), a procedure where blood is treated with light to reduce immune activity, in treating cGVHD.

What are the potential side effects?

Possible side effects may include reactions at the infusion site from Axatilimab, such as redness or pain, and symptoms related to immune system changes. ECP might cause dizziness or nausea during the procedure.

Eligibility Criteria

Inclusion Criteria

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

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I am 12 years old or older.

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I can care for myself but may not be able to do heavy physical work.

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I have received a stem cell transplant from a donor.

Exclusion Criteria

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

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I do not have a lens in my eye due to surgery or a condition, or I have a disease that makes my skin or eyes very sensitive to light.

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My cancer is currently getting worse.

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I have a history of myositis.

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I have had my spleen removed.

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I have had lung inflammation not caused by an infection.

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I am currently experiencing bleeding in my digestive tract.

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I have not received CSF-1R targeted therapies before.

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I do not have AIDS or active hepatitis B or C.

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I have had pancreatitis before.

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My insurance won't cover the ECP procedure.

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I have had a bad reaction or no improvement from ECP treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 24 weeks, 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 24 weeks, 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 24 weeks, 1 year 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 Overall Response Rate (ORR)

Secondary study objectives

Change in Quality of life (QoL) as measured by the modified Lee Symptom Scale (mLSS) score

Change in cumulative dose of corticosteroid usage

Duration of response (DOR)

+5 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: Axatilimab in combination with ECP GroupExperimental Treatment2 Interventions

Participants in this group will receive Axatilimab in combination with extracorporeal photopheresis (ECP) therapy for up to seven (7) four-week cycles. Total participation duration is about 15 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Extracorporeal Photopheresis

2004

Completed Phase 2

~40

Axatilimab

2017

Completed Phase 1

~50