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
Treatment
Study Type
Interventional
Phase
Phase I

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
3 Months
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
20-000944
Category
Oncology
Pediatrics
Contact
Andres Vargas Gonzalez
Location
  • UCLA Westwood
For Providers
NCT No.
NCT02963064
For detailed technical eligibility, visit ClinicalTrials.gov.