Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This is a Phase 1/2, Open-label, Dose Escalation study to investigate SNDX-6352 in
participants with active chronic graft versus host disease (cGVHD).
Phase
Phase 1/Phase 2
Funding Agency/Sponsor
Industrial
Disease
Thoracic Oncology
Enrollment Eligibility
Key Inclusion Criteria:
1. Participant must be 6 years of age or older, at the time of signing the informed
consent.
2. Participants who are allogeneic hematopoietic stem cell transplant (HSCT) recipients
with cGVHD requiring systemic immune suppression.
3. Participants with active cGVHD who have received at least 2 lines of therapy.
Participants 18 or older 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. Participants 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 (if
aged 16 years or older); Lansky Performance Score of ≥60 (if less than 16 years).
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 study
requirements and restrictions.
Key Exclusion Criteria:
1. Has acute GVHD without manifestations of cGVHD.
2. Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of relapse of
the underlying cancer or post-transplant lymphoproliferative disease at the time of
screening.
3. History or other evidence of severe illness, uncontrolled infection or any other
conditions that would make the participant, in the opinion of the Investigator,
unsuitable for the study.
4. Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV)
or hepatitis B virus (HBV).
5. 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 (for example, 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).
6. Female participants who are pregnant or breastfeeding.
7. Previous exposure to study intervention or known allergy/sensitivity to study
intervention.
8. 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).
9. Receiving an investigational treatment within 28 days of study entry.