A Clinical Study to Evaluate the Use of a Cryopreserved Formulation of OTL-103 in Subjects With W… (NCT03837483) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Clinical Study to Evaluate the Use of a Cryopreserved Formulation of OTL-103 in Subjects With Wiskott-Aldrich Syndrome
United States, Italy10 participantsStarted 2019-01-21
Plain-language summary
This is an open-label, single arm study to evaluate the cryopreserved formulation of OTL-103 Gene Therapy. OTL-103 consists of autologous CD34+ hematopoietic stem cells in which the gene encoding for the Wiskott-Aldrich Syndrome is introduced by means of a third generation lentiviral vector.
Who can participate
Age range65 Years
SexALL
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Inclusion Criteria:
* Age: up to 65 years
* Diagnosis of WAS defined by genetic mutation and at least one of the following criteria:
* Severe Wiskott-Aldrich Syndrome (WAS) gene mutation, defined by literature data (genotype/phenotype studies).;
* Absent WASP expression, assessed by flow cytometry;
* Severe clinical score (Zhu clinical score ≥ 3);
* No human leukocyte antigen (HLA)-identical related donor available for hematopoietic stem cells transplant (HSCT).
Exclusion Criteria:
* End-organ dysfunction, severe active infection not responsive to treatment or other severe disease or clinical condition which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
* Malignant neoplasia (except local skin cancer) or a documented history of hereditary cancer syndrome.
* Myelodysplasia, cytogenetic alterations characteristic of myelodysplastic syndrome and acute myeloid leukaemia , or other serious haematological disorders
* Documented human immunodeficiency virus (HIV) infection
* Prior allogeneic hematopoietic stem cell transplantation, with evidence of residual cells of donor origin
* Symptomatic herpes zoster, not responsive to specific treatment
* Evidence of acute tuberculosis
* Acute or chronic stable Hepatitis B
* Presence of positive Hepatitis C RNA test result at screening
* Patients not eligible for mobilization protocols in order to obtain CD34+ cells
* Previous Gene Therapy
What they're measuring
1
Annualized rate of severe infections from 6 to 18 months after gene therapy compared with 1 year before gene therapy
Timeframe: 18 months
2
Annualized rate of moderate and severe bleeding episodes up to 1 year after gene therapy compared with 1 year before gene therapy