ACUTE MYELOID LEUKEMIA; AML Clinical Trial
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)
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 8, 2023 |
Est. primary completion date | October 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
United States | City of Hope Comprehensive Cancer Center | Duarte | California |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Huntsman Cancer Institute - University of Utah | Salt Lake City | Utah |
United States | Fred Hutchinson Cancer Research Center | Seattle | Washington |
United States | Stanford University | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Jasper Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of subjects experiencing adverse events and serious adverse events will be assessed. | The number of subjects experiencing adverse events and serious adverse events will be assessed. | Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period) | |
Primary | The number of dose limiting toxicities will be assessed. | The number of dose limiting toxicities will be assessed. | Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period) | |
Primary | The type of dose limiting toxicities will be assessed. | The type of dose limiting toxicities will be assessed. | Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06387420 -
A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia
|
Phase 1/Phase 2 |