A Phase 1/2 Study to Evaluate SNDX- 6352 in Subjects With Active cGVHD
This is a Phase 1/2, Open-label, Dose Escalation study to investigate SNDX-6352 in subjects with active cGVHD.
- Chronic Graft-versus-host-disease
- Eligible Ages
- Over 12 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Subject must be 12 years of age or older, at the time of signing the informed consent.
- Subjects who are allogeneic HSCT recipients with cGVHD requiring systemic immune suppression.
- Subjects with active cGVHD who have erythematous rash involving >25% body surface area or a NIH mouth score of >4 must have received prior ibrutinib therapy.
a. Active cGVHD is defined as the presence of signs and symptoms of cGVHD per 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
4. Subjects may have persistent active acute and cGVHD manifestations (overlap syndrome), as defined by 2014 NIH Consensus Development Project on Criteria for Clinical trials in cGVHD.
5. Karnofsky Performance Scale of ≥60 with a life expectancy of at least 3 months.
6. Adequate organ and bone marrow functions.
7. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.
- Has acute GVHD without manifestations of cGVHD.
- Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
- History or other evidence of severe illness, uncontrolled infection or any other conditions that would make the subject, in the opinion of the Investigator, unsuitable for the study.
- Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV).
- Diagnosed with another malignancy (other than malignancy for which transplant was performed) within 3 years of enrollment, unless previously treated with curative intent and must be approved by Sponsor medical monitor (e.g., completely resected basal cell or squamous cell carcinoma of the skin, resected in situ cervical malignancy, resected breast ductal carcinoma in situ, or low-risk prostate cancer after curative resection).
- Female subjects who is pregnant or breastfeeding.
- Previous exposure to study intervention or known allergy/sensitivity to study intervention.
- Taking agents other than a corticosteroid and one calcineurin inhibitor (CNI) for treatment of cGVHD (This does not include agents being prescribed expressly for the treatment of acute GVHD).
- Receiving an investigational treatment within 28 days of study entry.
- Phase 1/Phase 2
- Study Type
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- The dose-escalation phase is a sequential group (dose-escalating) treatment study that is open-label. The dose-expansion phase is a parallel group treatment study with open-label cohorts.
- Primary Purpose
- None (Open Label)
Cohorts of escalating dose levels of SNDX-6352
|Escalating dose levels of SNDX-6352 to establish the optimal biologic dose (OBD) and recommended Phase 2 dose (RP2D). IV infusion; SNDX-6352 at a dose of 0.15 mg/kg to 3 mg/kg.||
Phase 2 Dose Expansion
|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.||
- Syndax Pharmaceuticals
Study ContactChristine Quaranto
This is dose escalation and dose expansion study in patients with active chronic graft versus host disease (cGVHD) who have received at least 2 lines of prior therapy.