JSP191 Antibody Targeting Conditioning in MDS/AML Patients Undergoing Hematopoietic Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT04429191|
Recruitment Status : Recruiting
First Posted : June 12, 2020
Last Update Posted : July 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|MYELODYSPLASTIC SYNDROME; MDS ACUTE MYELOID LEUKEMIA; AML||Biological: Humanized anti-CD117 Monoclonal Antibody (JSP191)||Phase 1|
This is a Phase 1 study to evaluate the safety and tolerability of an antibody conditioning regimen known as JSP191, in combination with low dose radiation and fludarabine, in patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia undergoing blood stem cell transplantation.
Blood Stem Cell transplantation offers the only potentially curative therapy for many forms of Acute Myeloid Leukemia (AML) and for Myelodysplastic Syndrome (MDS). While standard of care conditioning regimens given prior to blood Stem Cell transplantation, such as standard TBI/Flu conditioning is well tolerated, they are associated with increased rates of relapse due to persistence of disease causing Hematopoietic Stem Cells and insufficient graft versus leukemia effect.
The biological conditioning regimen, JSP191, is an antibody that binds to CD117. CD117 is the receptor for Stem Cell Factor on blood forming cells. CD117 binding to Stem Cell Factor is critical for survival and maintenance of blood forming stem cells.
The binding of JSP191 to CD117 blocks CD117 from binding to Stem Cell Factor on blood forming stem cells. In the absence of CD117/Stem Cell Factor binding, hematopoietic stem cells that are currently occupying the bone marrow niches in MDS/AML patients are depleted.
This study will investigate the safety and tolerability of adding JSP191 (an anti-CD117 monoclonal antibody therapy) to standard TBI/Flu conditioning regimen in adults with AML and MDS undergoing hematopoietic stem cell transplant.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study to Evaluate the Safety and Tolerability of JSP191 in Combination With Low Dose Radiation and Fludarabine in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Undergoing Hematopoietic Cell Transplantation|
|Actual Study Start Date :||July 8, 2020|
|Estimated Primary Completion Date :||February 15, 2021|
|Estimated Study Completion Date :||May 8, 2021|
Experimental: Blood Stem Cell Transplant w/ anti-CD117 conditioning
The study plans to assess approximately 3 planned dose cohorts of JSP191: 0.3 mg/kg, 0.6 mg/kg, and 1.0 mg/kg. Patients will receive a single dose of intravenous JSP191 antibody followed by monitoring for antibody clearance. Once the antibody has cleared below a certain level, patients will receive stem cell transplant and be monitored for hematopoietic recovery.
Biological: Humanized anti-CD117 Monoclonal Antibody (JSP191)
Procedure: single intravenous infusion of JSP191 antibody
Other Name: JSP191
- The number of subjects experiencing adverse events and serious adverse events will be assessed. [ Time Frame: Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period) ]The number of subjects experiencing dose limiting toxicities including adverse events and serious adverse events will be assessed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04429191
|Contact: Clinical Trials, Jasper Therapeutics, Inc.||650-549-1417||ClinicalTrials@JasperTherapeutics.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Lori Muffly, MD,MS firstname.lastname@example.org|
|Principal Investigator:||Lori Muffly, MD,MS||Stanford University|
|Principal Investigator:||Andrew Artz, MD,MS||City of Hope Medical Center|
|Principal Investigator:||Bart Scott, MD||Fred Hutchinson Cancer Research Center|
|Principal Investigator:||Catherine Lee, MD||Huntsman Cancer Institute/ University of Utah|
|Principal Investigator:||Arpita Gandhi, MD||Oregon Health and Science University|
|Principal Investigator:||Ankur Varma, MD,PhD||Rush University Medical Center|