A phase ib, open-label, randomized, dose-finding, multicenter study to evaluate the safety, pharmacokinetics, and efficacy of GDC-8264 in combination with standard of care in the treatment of acute graft-versus-host disease in patients who have undergone allogeneic hematopoietic stem cell transplantation

Genentech, Inc.0 个研究点目标入组 40 人开始时间: 2022年11月9日最近更新: 2023年12月19日

试验速览

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•1. Signed Informed Consent Form (ICF) from the participant or legal representative
•2. Age =18 years at time of signing ICF
•3. Diagnosis of post-allogeneic hematopoietic stem cell transplantation (HSCT) aGVHD at screening, with the following aspects of HSCT permissible:
•3.1. Any malignant or non-malignant indication leading to HSCT
•3.2. Any HSCT donor type (e.g., related, unrelated) or stem cell source (i.e., bone marrow, peripheral blood, cord blood)
•3.3. Any GVHD prophylaxis regimen
•3.4. Any conditioning regimen (i.e., myeloablative, reduced intensity, and non-myeloablative)
•4. Evidence of engraftment post-transplant
•5. Diagnosis of high-risk aGVHD, per refined Minnesota high-risk aGVHD criteria during screening
•6. Initiation of treatment with systemic corticosteroids for aGVHD at a dose of prednisone =2 mg/kg/day 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

•1. 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
•2. Prior receipt of more than one allogeneic HSCT
•3. Prior systemic treatment for aGVHD, except for the standard of care corticosteroid treatment initiated as part of this trial
•4. Diagnosis of chronic GVHD or overlap syndrome
•5. 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)
•6. Severe organ dysfunction (e.g., acute liver failure, renal failure requiring dialysis, ventilator support, or vasopressor therapy)
•7. 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

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