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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 months

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

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

Primary outcome measures

To characterize the OBD and determine the RP2D of SNDX-6352 in participants with cGVHD [Phase 1]

To evaluate the efficacy of SNDX 6352 in participants with cGVHD [Phase 2]

Secondary outcome measures

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]

+12 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%

Back pain

40%

Arthralgia

40%

Constipation

40%

Pain at biopsy site

40%

Blood LDH increased

20%

Hypokalemia

20%

Arthritis

20%

Headache

20%

Anorexia

20%

Rash acneiform

20%

Pain in Extremity

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%

Study treatment Arm

Durvalumab and SNDX-6352

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

2017

Completed Phase 2

~50

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Syndax PharmaceuticalsLead Sponsor

48 Previous Clinical Trials

2,733 Total Patients Enrolled

Michael L Meyers, MD, PhDStudy DirectorSyndax Pharmaceuticals

Vedran Radojcic, M.D.Study DirectorSyndax Pharmaceuticals

1 Previous Clinical Trials

241 Total Patients Enrolled

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

Frequently Asked Questions

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

Have any other experiments been carried out with SNDX-6352?

"Presently, there are 3 active trials for SNDX-6352 with none in Phase 3. The main research site is Duarte, California; however, a total of 137 locations are running investigations on this medication."

Answered by AI

What is the aggregate size of participants engaging in this experiment?

"This clinical trial is not presently recruiting new participants. Initially posted on November 1st 2018, the last update was August 18th 2022. If searching for other trials instead, there are 169 studies looking to enrol patients with a particular condition and 3 active studies seeking applicants for SNDX-6352."

Answered by AI

Are there currently opportunities for individuals to join this research endeavor?

"According to clinicaltrials.gov, applicants are not being accepted at this time for the trial that was first posted on November 1st 2018 and most recently updated August 18th 2022. Nevertheless, 172 other studies are currently enrolling participants."

Answered by AI

What objectives is this trial seeking to attain?

"The primary aim of this 6 month long clinical trial is to gauge the efficacy of SNDX 6352 in cGVHD patients. Additionally, researchers are evaluating axatilimab's safety and tolerability by assessing adverse events using NCI CTCAE version 5.0. Vz and %AUCextra will also be computed as secondary outcomes for Phase 1 participants respectively."

Answered by AI

Is this the inaugural research project of its type?

"The journey of SNDX-6352 began in 2018 with the first trials sponsored by Syndax Pharmaceuticals. After successfully completing Phase 1 & 2, 3 clinical studies are now active across 16 nations and 52 cities worldwide."

Answered by AI

How many centers are carrying out this clinical investigation?

"This clinical trial is open to patients at a variety of sites, including Washington University School of Medicine in Saint Louis, Missouri; the University of Utah Health Huntsman Cancer Institute in Salt Lake City, Utah; and Vanderbilt-Ingram Cancer Center in Nashville, Tennessee. An additional 11 locations are also participating."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD

2018. "A Phase 1/2 Study to Evaluate SNDX- 6352 in Participants With Active cGVHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03604692.

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