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Axatilimab for Graft-versus-Host Disease

University of Miami, Miami, FL
Graft-versus-Host DiseaseAxatilimab - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Chronic Graft-versus-Host Disease

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Niraparib
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rHSC-DIPGVax

Study Objectives

2 Primary · 33 Secondary · Reporting Duration: Approximately 30 months

Approximately 12 months
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)
Number of Participants with Anti-Drug Antibody
Observed Maximum Plasma Concentration (Cmax)
Time to Observed Maximum Plasma Concentration (Tmax)
Approximately 30 months
Number of Participants who Discontinue CNIs
Number of Participants who Discontinue Corticosteroid Use
Number of Participants with Treatment-emergent Adverse Events
Organ-specific Response Rate
Percent Reductions in Average Daily Doses (or Equivalent) of Calcineurin Inhibitors (CNI)
Percent Reductions in Average Daily Doses (or Equivalent) of Corticosteroid
Month 30
To evaluate the safety and tolerability of axatilimab in patients with cGVHD
Approximately 6 Months
Overall response rate in the first 6 cycles
To evaluate key secondary measures of clinical benefit for patients with cGVHD
Baseline, approximately 12 months
Change from Baseline in Circulating Monocyte Levels
Up to Day 169
Duration of Response
Number of Participants with a >5-Point Improvement in Normalized Score on the Modified Lee Symptom Scale
Overall Response Rate
Sustained Response Rate
approximately 12 months
Area under the plasma concentration-time curve from time 0 to infinity [Phase 1]
Area under the plasma concentration-time curve from time 0 to time of last measurable concentration [Phase 1]
Clearance
Observed maximum plasma concentration
Percentage of estimated part for the calculation of AUC0-inf
Presence of Anti-Drug Antibody
Terminal disposition phase rate constant
Terminal phase half-life
Terminal phase volume of distribution
Time to observed maximum plasma concentration
To determine or assess the baseline in monocyte level with response
To determine or assess the changes in monocyte level with response
approximately 30 Months
Calcineurin inhibitor discontinuation
Calcineurin inhibitor reduction
Corticosteroid discontinuation
Corticosteroid reduction

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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1
Niraparib
1
SRF388
1
rHSC-DIPGVax

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

6 Treatment Groups

Axatilimab (SNDX-6352) Dose Cohort 1 - 0.3 mg/kg IV Q2W
1 of 6
Axatilimab (SNDX-6352) Dose Cohort 2 - 1 mg/kg IV Q2W
1 of 6
Axatilimab (SNDX-6352) Dose Cohort 3 - 3 mg/kg IV Q4W
1 of 6
Axatilimab Dose Cohort 1
1 of 6
Axatilimab Dose Cohort 2
1 of 6
Axatilimab Dose Cohort 3
1 of 6

Active Control

Experimental Treatment

241 Total Participants · 6 Treatment Groups

Primary Treatment: Axatilimab · No Placebo Group · Phase 2

Axatilimab Dose Cohort 1
Drug
Experimental Group · 1 Intervention: Axatilimab · Intervention Types: Drug
Axatilimab Dose Cohort 2
Drug
Experimental Group · 1 Intervention: Axatilimab · Intervention Types: Drug
Axatilimab Dose Cohort 3
Drug
Experimental Group · 1 Intervention: Axatilimab · Intervention Types: Drug
Axatilimab (SNDX-6352) Dose Cohort 1 - 0.3 mg/kg IV Q2W
Drug
ActiveComparator Group · 1 Intervention: axatilimab · Intervention Types: Drug
Axatilimab (SNDX-6352) Dose Cohort 2 - 1 mg/kg IV Q2W
Drug
ActiveComparator Group · 1 Intervention: axatilimab · Intervention Types: Drug
Axatilimab (SNDX-6352) Dose Cohort 3 - 3 mg/kg IV Q4W
Drug
ActiveComparator Group · 1 Intervention: axatilimab · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 30 months

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor
41 Previous Clinical Trials
2,295 Total Patients Enrolled
Michael Meyers, M.D., Ph.D.Study DirectorSyndax Pharmaceuticals, Inc.
Vedran Radojcic, M.D.Study DirectorSyndax Pharmaceuticals
1 Previous Clinical Trials
40 Total Patients Enrolled

Eligibility Criteria

Age Any Age · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have chronic graft-versus-host disease (cGVHD) that does not respond to treatment or has come back after responding to previous treatment. This is based on specific criteria that evaluate the disease's activity and symptoms.
You are allowed to take CNI or sirolimus, but it is not mandatory.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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