← Back to Search

Monoclonal Antibodies

Axatilimab for Graft-versus-Host Disease (AGAVE-201 Trial)

Q: In what areas is this clinical study accessible?

This clinical trial is conducted at 52 different medical centres, with key sites in Seattle, Montréal and Salt Lake City. Prospective participants should look for the location closest to them so as to minimize transportation needs.

Q: What research has been conducted involving Axatilimab in the past?

Axatilimab was initially explored in 2018 at City of Hope, leading to one completed clinical trial. Nowadays, there are 3 studies recruiting participants; some of these can be found within Seattle's medical community.

Q: Has Axatilimab received governmental certification to be released on the market?

Axatilimab's safety is well-documented, so it received a rating of 2. However, no clinical trials have evaluated its efficacy yet.

Q: How many participants have been recruited for this medical experiment?

This investigation is no longer seeking potential participants. It was initially posted on March 4th 2021 and received its most recent update October 27th 2022. However, there are currently 169 trials searching for patients with a medical condition as welll 3 studies looking to recruit subjects for Axatilimab treatment.

Q: Are new participants being enrolled for this research effort at present?

This therapeutic study has finished recruiting participants. It was initially made public on March 4th of this year and underwent a final update on October 27th 2022. For those hoping to join other clinical trials, there are 169 studies actively accepting patients with disease as well as 3 programs involving Axatilimab currently enrolling individuals.

Q: Has this scientific endeavor been undertaken before?

Research into axatilimab has been ongoing since 2018, where an initial trial sponsored by Syndax Pharmaceuticals was conducted. This led to it receiving Phase 1 &#x26; 2 drug approval and there are currently 3 active studies spanning 52 cities and 16 countries.

Phase 2

Waitlist Available

Research Sponsored by Syndax Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Scale of ≥60 (if aged 16 years or older); Lansky Performance Score of ≥60 (if aged <16 years)

Participants who are allogeneic hematopoietic stem cell transplantation (HSCT) recipients with active cGVHD requiring systemic immune suppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 30 months

Awards & highlights

AGAVE-201 Trial Summary

This trial is testing a new drug, axatilimab, to see if it is effective, safe, and tolerated in people with cGVHD who have had two or more prior lines of systemic therapy.

Who is the study for?

This trial is for people aged 2 or older with chronic graft versus host disease (cGVHD) who've had at least two prior systemic therapies. They must have a certain level of physical function, adequate organ and bone marrow function, and not be pregnant or breastfeeding. Participants can't join if they're on other cGVHD treatments besides corticosteroids/CNI/mTOR inhibitors, in another study, have been exposed to CSF1-R targeted therapies, or have severe illnesses.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of axatilimab at three different doses in patients with active cGVHD that's come back or hasn't responded to treatment after an allogeneic stem cell transplant. It's a Phase 2 trial focusing on those who've tried multiple treatments already.See study design

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions related to axatilimab across the different dosages being tested.

AGAVE-201 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I can care for myself but may not be able to do active work or play.

Select...

I had a stem cell transplant and need treatment for ongoing graft-versus-host disease.

Select...

My kidney function, measured by creatinine clearance, is adequate.

Select...

My chronic GVHD hasn't improved after two different treatments.

AGAVE-201 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate in the First 6 Cycles

Secondary outcome measures

AUC from Time 0 to Infinity (AUC0-inf)

Area Under the Plasma Concentration-time Curve (AUC) from Time 0 to Time of Last Measurable Concentration (AUC0-t)

Change from Baseline in Circulating Monocyte Levels

+13 more

AGAVE-201 Trial Design

3Treatment groups

Experimental Treatment

Group I: Axatilimab Dose Cohort 3Experimental Treatment1 Intervention

Participants will be administered axatilimab 3 mg/kg IV every 4 weeks for up to 2 years.

Group II: Axatilimab Dose Cohort 2Experimental Treatment1 Intervention

Participants will be administered axatilimab 1 mg/kg IV every 2 weeks for up to 2 years.

Group III: Axatilimab Dose Cohort 1Experimental Treatment1 Intervention

Participants will be administered axatilimab 0.3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks for up to 2 years.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor

48 Previous Clinical Trials

2,533 Total Patients Enrolled

Michael Meyers, M.D., Ph.D.Study DirectorSyndax Pharmaceuticals, Inc.

Vedran Radojcic, M.D.Study DirectorSyndax Pharmaceuticals

1 Previous Clinical Trials

41 Total Patients Enrolled

Media Library

Axatilimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04710576 — Phase 2

Graft-versus-Host Disease Research Study Groups: Axatilimab Dose Cohort 1, Axatilimab Dose Cohort 2, Axatilimab Dose Cohort 3

Graft-versus-Host Disease Clinical Trial 2023: Axatilimab Highlights & Side Effects. Trial Name: NCT04710576 — Phase 2

Axatilimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04710576 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what areas is this clinical study accessible?

"This clinical trial is conducted at 52 different medical centres, with key sites in Seattle, Montréal and Salt Lake City. Prospective participants should look for the location closest to them so as to minimize transportation needs."

Answered by AI

What research has been conducted involving Axatilimab in the past?

"Axatilimab was initially explored in 2018 at City of Hope, leading to one completed clinical trial. Nowadays, there are 3 studies recruiting participants; some of these can be found within Seattle's medical community."

Answered by AI

Has Axatilimab received governmental certification to be released on the market?

"Axatilimab's safety is well-documented, so it received a rating of 2. However, no clinical trials have evaluated its efficacy yet."

Answered by AI

How many participants have been recruited for this medical experiment?

"This investigation is no longer seeking potential participants. It was initially posted on March 4th 2021 and received its most recent update October 27th 2022. However, there are currently 169 trials searching for patients with a medical condition as welll 3 studies looking to recruit subjects for Axatilimab treatment."

Answered by AI

Are new participants being enrolled for this research effort at present?

"This therapeutic study has finished recruiting participants. It was initially made public on March 4th of this year and underwent a final update on October 27th 2022. For those hoping to join other clinical trials, there are 169 studies actively accepting patients with disease as well as 3 programs involving Axatilimab currently enrolling individuals."

Answered by AI

Has this scientific endeavor been undertaken before?

"Research into axatilimab has been ongoing since 2018, where an initial trial sponsored by Syndax Pharmaceuticals was conducted. This led to it receiving Phase 1 & 2 drug approval and there are currently 3 active studies spanning 52 cities and 16 countries."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)

2021. "A Study of Axatilimab at 3 Different Doses in Participants With Chronic Graft Versus Host Disease (cGVHD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04710576.

All > Gvhd