JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation

Trial ID or NCT#

NCT04429191

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * AML/MDS as defined by specific criteria, including but not limited to the following subtypes:
    1. 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
      1. Key
Exclusion Criteria:
  1. * Patients with any acute or uncontrolled infections* Patients receiving any other investigational agents* Patients with active non-hematologic malignancy* Prior allogeneic hematologic cell transplantation
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Investigator(s)

Lori Muffly
Lori Muffly
Hematologist, Blood and marrow transplant specialist, Blood and marrow transplant specialist, Hematologist-Oncologist
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

Michelle Chin
650-721-4183

View on ClinicalTrials.gov