Alpha/Beta T-cell Depleted Blood-forming Stem Cell Transplant From Related or Unrelated Donors for Blood Diseases in Children and Young Adults

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT04806347
Phase
PHASE1
Status
Recruiting
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Conditions

  • Blood Disease

Eligibility Criteria

Sex
ALL
Age
3 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • TCRαβ+/CD19+ depleted Hematopoietic stem cell (HSC) graft — BIOLOGICAL
    After undergoing a disease specific conditioning regimen (standard of care), participants will receive peripheral blood stem cell transplant from a haploidentical donor or closely matched unrelated donor, depleted of TCR αβ+ and CD19+ cells using the CliniMACS TCR α/β-biotin and CD19 Systems.
  • CliniMACS® System — DEVICE
    The CliniMACS Cell Selection System is based on magnetic-activated cell sorting mechanism. The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures.

Study Details

This study is being done to see if the investigators can take peripheral blood stem cells from either an adult family member or a closely matched unrelated donor, and run them through a special lab instrument to remove alpha/beta T cells and B cells and then give them to the patient to treat disease. This is an experimental way of doing a hematopoietic stem cell transplant (HSCT). The investigators want to see if the new stem cells will grow without bad graft vs. host disease (GVHD). This treatment approach is experimental in the United States.

Key Dates

First listed
Mar 19, 2021
Start date
Oct 31, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2030

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Participants will undergo a conditioning regimen, specific for the original disease, After that peripheral blood stem cell transplant from a haploidentical donor or closely matched unrelated donor, depleted of TCRαβ+ and CD19+ cells using the CliniMACS TCR α/β-biotin and CD19 Systems will be administered intravenously on Day 0 to all participants.

Primary Outcome Measure

Incidence of grade III-IV acute graft-versus-host disease (GVHD) [ Time Frame: 100 days post transplantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
American Family Children's HospitalMadisonWisconsin53792-

Find similar trials in Madison, WI

By research site
American Family Children's Hospital· Madison, WI

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