JSP191 Antibody Targeting Conditioning in SCID Patients
NCT ID: NCT02963064
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2017-03-20
2025-07-07
Brief Summary
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Detailed Description
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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 SCID patients exit from the bone marrow.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Blood Stem Cell Transplant w/ anti-CD117 conditioning
The study will enroll two groups: Group A: previously transplanted SCID patients; Group B: newly diagnosed SCID. The study plans to assess JSP191 in different dose cohorts. Patients 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.
Humanized anti-CD117 Monoclonal Antibody (JSP191)
Procedure: single intravenous infusion of JSP191 antibody
Interventions
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Humanized anti-CD117 Monoclonal Antibody (JSP191)
Procedure: single intravenous infusion of JSP191 antibody
Eligibility Criteria
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Inclusion Criteria
1. T-, B+, NK-: IL-2Rcγ deficient, JAK3-deficient (no longer enrolling)
2. T-, B-, NK+: RAG1/2 deficient, Artemis-deficient
3. T-, B+, NK+: IL7Rα deficient, CD3 subunit deficient, CD45 deficient (no longer enrolling) OR Variant SCID with absent or low T cell function, Omenn syndrome, Leaky SCID, Reticular dysgenesis, Adenosine deaminase deficiency, and Purine nucleoside phosphorylase deficiency may be included after consultation with the medical monitor.
2. Patients with human leukocyte antigen (HLA) matched related or unrelated donors
3. Adequate end organ function as defined in study protocol
4. Age ≤ 12 years
5. Prior donor of appropriate age (≥ 5 years old) available for re-collection of stem cells
6. Previous allogeneic Hematopoietic Cell Transplantation HCT (≥ 6 months post initial transplant) with poor graft function
Exclusion Criteria
2. Patients receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy
3. Patients with active malignancies
4. Active GVHD within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD
3 Months
12 Years
ALL
No
Sponsors
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Jasper Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rajni A. Agarwal-Hashmi, M.D.
Role: PRINCIPAL_INVESTIGATOR
Lucile Packard Children's Hospital
Christopher C. Dvorak, M.D.
Role: PRINCIPAL_INVESTIGATOR
UCSF Benioff's Children's Hospital
Joseph H. Oved, M.D.
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Theodore B. Moore, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Sharat Chandra, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Christen L Ebens, M.D., MPH
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Harry L Malech, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institutes of Health Clinical Center (CC)
Shanmuganathan Chandrakasan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Healthcare of Atlanta
Neena Kapoor, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Los Angeles
Elizabeth D Hicks, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Susan Prockop, M.D.
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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UCLA Mattel Children's Hospital
Los Angeles, California, United States
Lucile Packard Children's Hospital
Palo Alto, California, United States
UCSF Benioff's Children's Hospital
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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JAS-BMT-CP-001
Identifier Type: -
Identifier Source: org_study_id
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