SNDX-6352 for Graft-versus-Host Disease

Phase 1 & 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through the first 28 days from the first dose of sndx-6352 or administration of the third dose (cycle 2 day 1), whichever is later (from c1d1 to c2d1)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug, SNDX-6352, to see if it is effective and safe in treating patients with active chronic graft versus host disease.

Who is the study for?

This trial is for people aged 6 and older with chronic graft versus host disease (cGVHD) who've had at least two prior treatments. Adults with severe skin or mouth symptoms must have tried a drug called ibrutinib. Participants need to be in stable condition, able to consent, and not pregnant or breastfeeding. They can't join if they have active cancer, acute GVHD without chronic symptoms, serious illnesses, HIV/HBV/HCV infections, or are on certain other medications.

What is being tested?

The study tests axatilimab in patients with cGVHD that persists despite previous treatments. It's an open-label trial where everyone knows what treatment they're getting—axatilimab—and the doses may change as researchers learn more about its effects.

What are the potential side effects?

While specific side effects of axatilimab aren't listed here, similar drugs often cause immune reactions like fever or chills; organ inflammation; blood count changes; fatigue; nausea; and increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through the first 28 days from the first dose of sndx-6352 or administration of the third dose (cycle 2 day 1), whichever is later (from c1d1 to c2d1)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through the first 28 days from the first dose of sndx-6352 or administration of the third dose (cycle 2 day 1), whichever is later (from c1d1 to c2d1)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through the first 28 days from the first dose of sndx-6352 or administration of the third dose (cycle 2 day 1), whichever is later (from c1d1 to c2d1) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase 1: Number of Participants With DLTs

Phase 1: Recommended Phase 2 Dose (RP2D)

Phase 2: Overall Response Rate (ORR) as Assessed by the Number of Participants With Complete Response (CR) or Partial Response (PR) at Cycle 7 Day 1 (Day 168)

Secondary study objectives

Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Concentration for SNDX-6352

Phase 1: Changes From Baseline in Colony-Stimulating Factor-1 (CSF-1) and Interleukin (IL-34) Serum Concentrations

Phase 1: Number of Participants Positive for Anti-Drug Antibodies (ADA)

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2 Dose ExpansionExperimental Treatment1 Intervention

Phase 2, dose expansion, is an open-label design, evaluating the 1 mg/kg dose in a larger sample size. IV infusion; axatilimab at a dose of 1 mg/kg.

Group II: Cohorts of escalating dose levels of axatilimabExperimental Treatment1 Intervention

Escalating dose levels of axatilimab to establish the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D). Intravenous (IV) infusion; axatilimab at a dose of 0.15 milligrams (mg)/kilogram (kg) to 3 mg/kg.

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