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Monoclonal Antibody
JSP191 for MDS/AML
Phase 1
Waitlist Available
Led By Lori Muffly, MD,MS
Research Sponsored by Jasper Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year post donor cell transplant (28 days dose limiting toxicity period)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests JSP191, an antibody that helps clear out diseased blood cells, in adults with MDS or AML who are getting a stem cell transplant. By blocking a critical connection on blood cells, JSP191 makes room for new, healthy stem cells.
Eligible Conditions
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year post donor cell transplant (28 days dose limiting toxicity period)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post donor cell transplant (28 days dose limiting toxicity period)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The number of dose limiting toxicities will be assessed.
The number of subjects experiencing adverse events and serious adverse events will be assessed.
The type of dose limiting toxicities will be assessed.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Blood Stem Cell Transplant w/ anti-CD117 conditioningExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Jasper Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
179 Total Patients Enrolled
Lori Muffly, MD,MSPrincipal InvestigatorStanford University
Andrew Artz, MD,MSPrincipal InvestigatorCity of Hope Medical Center
Bart Scott, MDPrincipal InvestigatorFred Hutchinson Cancer Center
Catherine Lee, MDPrincipal InvestigatorHuntsman Cancer Institute/ University of Utah
2 Previous Clinical Trials
9 Total Patients Enrolled
Arpita Gandhi, MDPrincipal InvestigatorOregon Health and Science University
Ankur Varma, MD,PhDPrincipal InvestigatorRush University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Rewritten Criteria:
1. You currently have an infection that is not being treated or managed properly.
2. You are currently receiving an experimental medication for another study.
3. You have an active cancer that is not a blood cancer.
4. You have had a bone marrow transplant using cells from another person.
Research Study Groups:
This trial has the following groups:- Group 1: Blood Stem Cell Transplant w/ anti-CD117 conditioning
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.