Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults


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Trial ID: NCT04249830


The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.

Official Title

Allogeneic Hematopoietic Stem Cell Transplantation From an HLA-partially Matched Related or Unrelated Donor After TCR αβ+T Cells/CD19+ B Cell Depletion in Children and Young Adults Affected by Malignant or Non-Malignant Hematological Disorders

Stanford Investigator(s)


Inclusion Criteria:

   1. Age < 60 years and > 1 month;

   2. Life expectancy > 10 weeks;

   3. Patients deemed eligible for allogeneic HSCT per institutional guidelines;

   4. Patients with life-threatening hematological malignancies and non-malignant disorders
   that could benfit from HSCT;

   5. A minimum genotypic identical match of 5/10 is required;

   6. The donor and recipient must be identical, as determined by high resolution typing, in
   at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, and

   7. Lansky/Karnofsky score > 50;

   8. Signed written informed consent;

   9. Male and female subjects of childbearing potential must agree to use an effective
   means of birth control to avoid pregnancy throughout the transplant procedure, while
   on immunosuppression, and if the subject experiences any chronic GvHD.

Exclusion Criteria:

   1. Pregnant or lactating females;

   2. Greater than Grade II acute GvHD or severe, unmanaged chronic extensive GvHD due to a
   previous allograft at the time of inclusion;

   3. Dysfunction of liver (ALT/AST > 10 times upper normal value, or direct bilirubin > 3
   times upper normal value), or unmanageable dysfunction of renal function;

   4. Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive
   heart failure or left ventricular ejection fraction < 30%);

   5. Current active infectious disease (including positive HIV serology or viral RNA);

   6. Serious concurrent uncontrolled medical disorders;

   7. Lack of patient's/parents'/guardian's informed consent;

   8. Any severe concurrent disease which, in the judgement of the sponsor-investigator,
   would place the patient at increased risk during participation in the study.


biological: Allogeneic Stem Cell Transplant

device: CliniMACS TCR α/β Reagent Kit and CliniMACS CD19


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Study Team

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