Open
Actively Recruiting
JSP191 Antibody Targeting Conditioning in SCID Patients
About
Brief Summary
A Phase 1/2 study to evaluate the safety, tolerability, and efficacy of an antibody conditioning regimen, known as JSP191, in patients with Severe Combined Immune Deficiency undergoing blood stem cell transplantation
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Key Inclusion Criteria:
All patient groups must have:
- Typical SCID as defined by Primary Immune Deficiency Treatment Consortia including but not limited to the following subtypes:
- T-, B+, NK-: IL-2Rcγ deficient, JAK3-deficient
- T-, B-, NK+: RAG1/2 deficient, Artemis-deficient
- T-, B+, NK+: IL7Rα deficient, CD3 subunit deficient, CD45 deficient 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.
- 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, or concurrent biological, chemotherapy, or radiation therapy
- Patients with active malignancies
- Active GVHD within 6 months prior to enrollment, or on immunosuppressive therapy for GVHD
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Study Stats
Protocol No.
20-000944
Category
Other Cancer
Principal Investigator
Contact
Location
- UCLA Westwood