Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening.
- Evidence of engraftment post-transplant.
- Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening.
- Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone ≥ 2 milligrams per kilograms per day (mg/kg/day) by orally (PO) or methylprednisolone ≥ 2 mg/kg/day intravenously (or equivalent) in divided doses at
diagnosis and up to 3 days prior to or on the same day as initiation of GDC-8264 (Day 1), with no taper planned prior to Day 3.
Exclusion Criteria:
- Evidence of relapsed, progressing, or persistent malignancy, or treatment for relapse after transplant, or requirement for rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.
- Prior receipt of more than one allogeneic HSCT.
- Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial.
- Diagnosis of chronic GVHD or overlap syndrome.
- Uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment, or persistently positive blood cultures despite treatment, or any other evidence of severe sepsis).
- Severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy).
- Initiation or planned use of a marketed small molecule (excluding corticosteroids) or biologic therapy as treatment for aGVHD from the start of screening through the treatment period.
- of seizure or convulsions, except history of childhood febrile seizures.
- Higher risk of seizure, as determined by the investigator (including, but not limited to, history of stroke; known Alzheimer’s disease or non-Alzheimer’s dementia; structural brain disease including arteriovenous malformations or other mass lesions; clinical diagnosis of traumatic brain injury or concussion within previous 6 months).
Patients on concomitant medications known to increase the risk of seizure may continue taking those medications, provided they have not previously experienced a seizure at or below the dose level being administered prior to initiation of GDC-8264.
Eligibility last updated 10/9/23. Questions regarding updates should be directed to the study team contact.