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.
Recruiting
Phase 1
| Drug | Synonyms | Arms |
|---|---|---|
| Humanized anti-CD117 Monoclonal Antibody (JSP191) | JSP191 | Blood Stem Cell Transplant w/ anti-CD117 conditioning |
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.
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 are 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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Blood Stem Cell Transplant w/ anti-CD117 conditioning | Experimental | The phase 1a portion of 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 to determine the maximum tolerated dose for expansion. Subjects 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. The phase 1b portion of the study will enroll additional subjects at the expansion dose in order to further explore the safety, feasibility, and PK of that dose. |
|
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | 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) |
| Safety Issue: | |
| Description: | The number of subjects experiencing adverse events and serious adverse events will be assessed. |
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Jasper Therapeutics, Inc. |
June 11, 2021
