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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post donor cell transplant (28 days dose limiting toxicity period) for reporting.

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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