Clinical trial · Interventional
JSP191 Antibody Conditioning Regimen in MDS/AML Subjects Undergoing Allogenic Hematopoietic Stem Cell Transplantation
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)
NCT04429191CI-TRIAL-00052240completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ACUTE MYELOID LEUKEMIA; AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MYELODYSPLASTIC SYNDROME; MDS | Myelodysplastic Syndrome | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Humanized anti-CD117 Monoclonal Antibody (JSP191) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Blood Stem Cell Transplant w/ anti-CD117 conditioning
- description
- 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.
- interventionNames
- Biological: Humanized anti-CD117 Monoclonal Antibody (JSP191)
Primary outcomes (3)
- measure
- The number of subjects experiencing adverse events and serious adverse events will be assessed.
- timeFrame
- Up to 1 year post Donor Cell Transplant (28 days dose limiting toxicity period)
- description
- The number of subjects experiencing adverse events and serious adverse events will be assessed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMuffly L, Lee CJ, Gandhi A, Varma A, Scott BL, Patel SS, Shiraz P, Youn M, Yanagiba C, Arulprakasam J, Le A, Kwon HS, Long-Boyle J, Shizuru JA, Pang WW, Artz AS. Nonmyeloablative conditioning combined with the anti-CD117 antibody briquilimab in older adults with high-risk AML and MDS. Blood. 2026 May 28;147(22):2610-2620. doi: 10.1182/blood.2025031858. PMID 41785374