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JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation
Not Recruiting
Trial ID: NCT04429191
Purpose
This is a Phase 1a/b study to evaluate the safety and tolerability of an antibody
conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine,
in subjects with Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) undergoing
allogenic blood stem cell transplantation.
Official Title
A Phase 1a/b Study to Evaluate the Safety & Tolerability of JSP191 in Combination With a Regimen of Low Dose Radiation & Fludarabine in Subjects With MDS or AML Undergoing Hematopoietic Cell Transplantation (HCT)
Stanford Investigator(s)
Lori Muffly
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
Key Inclusion Criteria:
- AML/MDS as defined by specific criteria, including but not limited to the following
subtypes:
1. AML in CR
2. MDS < 5% BM blasts
3. MDS 5 - 10% BM blasts
4. AML not in CR or MDS > 10% BM blasts
- Patients with human leukocyte antigen (HLA) matched related or unrelated donors
- Adequate end organ function as defined in study protocol
Key Exclusion Criteria:
- Patients with any acute or uncontrolled infections
- Patients receiving any other investigational agents
- Patients with active non-hematologic malignancy
- Prior allogeneic hematologic cell transplantation
Intervention(s):
biological: Humanized anti-CD117 Monoclonal Antibody (JSP191)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Michelle Chin
650-721-4183