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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Alice Bertaina
Study ID
NCT04249830
Status
Recruiting
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Conditions

  • Hematologic Diseases

Eligibility Criteria

Sex
ALL
Age
1 Month - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Stem Cell Transplant — BIOLOGICAL
    The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.
  • CliniMACS TCR α/β Reagent Kit and CliniMACS CD19 — DEVICE
    The CliniMACS™system can be used to selectively enrich or reduce specific cell populations based on the magnetic cell selection (MACS) technology developed by Miltenyi Biotec. Cell mixtures can be separated in a magnetic field using one or more immunomagnetic- labeled antibodies specific for the cell types of interest (e.g.TCR αβ+ T cells and CD19+ B cells from HPC(A) products).

Study Details

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.

Key Dates

Start date
Feb 1, 2020
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
204 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stem Cell Transplant -Malignant
    The participant with a malignancy will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years.
  • Experimental: Stem Cell Transplant - Non-Malignant
    The participant with a non-malignant disease will undergo a stem cell transplant using donor cells that have been manipulated through an investigational device. Participants will be followed for outcomes for two years.
  • Other: Stem Cell Transplant - Compassionate
    Patients with malignant or non-malignant disorders who do not qualify for experimental arms but who may still benefit from participation in this study may be enrolled in this arm.

Primary Outcome Measure

Number of participants with grade II-IV acute GvHD after HSCT [ Time Frame: Through Day 100 after HSCT ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lucile Packard Children's HospitalPalo AltoCalifornia94306
SCGT Clinical Trials Program
[email protected]
(650) 497-2447
Tami John, MD (SUB_INVESTIGATOR)

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By research site
Lucile Packard Children's Hospital· Palo Alto, CA

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