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Monoclonal Antibodies

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 approximately 6 months
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.

Eligible Conditions
  • Chronic Graft-versus-Host Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 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
To evaluate the efficacy of SNDX 6352 in participants with cGVHD [Phase 2]
Secondary study objectives
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]
Best overall response (BOR), failure free survival (FFS), and duration of response (DOR) as defined by the 2014 NIH Consensus Development Project on Criteria for Clinical Trials in cGVHD [Phase 2]
+10 more

Side effects data

From 2024 Phase 2 trial • 5 Patients • NCT04301778
80%
Abdominal pain
80%
Fatigue
80%
AST increased
80%
CPK increased
60%
Nausea
60%
Weight loss
40%
Arthralgia
40%
Back pain
40%
Constipation
40%
Pain at biopsy site
40%
Blood LDH increased
20%
Anorexia
20%
Arthritis
20%
Hypokalemia
20%
Pain in Extremity
20%
Headache
20%
Rash acneiform
20%
Skin infection
20%
Hemorrhoidal hemorrhage
20%
ALT increased
20%
Ascites
20%
Anemia
20%
Vomiting
20%
Ruptured femoral pseudoaneurysm
20%
Diarrhea
20%
Edema limbs
20%
Generalized edema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and SNDX-6352

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; SNDX-6352 at a dose of 1 mg/kg.
Group II: Cohorts of escalating dose levels of SNDX-6352Experimental Treatment1 Intervention
Escalating dose levels of SNDX-6352 to establish the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D). Intravenous (IV) infusion; SNDX-6352 at a dose of 0.15 milligrams (mg)/kilogram (kg) to 3 mg/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SNDX-6352
2021
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor
48 Previous Clinical Trials
2,769 Total Patients Enrolled
Vedran Radojcic, M.D.Study DirectorSyndax Pharmaceuticals
1 Previous Clinical Trials
241 Total Patients Enrolled
Michael L Meyers, MD, PhDStudy DirectorSyndax Pharmaceuticals

Media Library

SNDX-6352 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03604692 — Phase 1 & 2
Graft-versus-Host Disease Research Study Groups: Cohorts of escalating dose levels of SNDX-6352, Phase 2 Dose Expansion
Graft-versus-Host Disease Clinical Trial 2023: SNDX-6352 Highlights & Side Effects. Trial Name: NCT03604692 — Phase 1 & 2
SNDX-6352 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03604692 — Phase 1 & 2
~6 spots leftby Nov 2025
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