Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05236764
Status
Active Not Recruiting

Conditions

  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia in Remission
  • Bone Marrow Failure Syndrome
  • Chronic Myeloid Leukemia
  • Cytopenia
  • Hemoglobinopathies
  • Hemophagocytic Lymphohistiocytoses
  • Myelodysplastic Syndromes
  • Primary Immunodeficiency Diseases
  • Severe Aplastic Anemia
  • Severe Chronic Active Epstein-Barr Virus Infection

Eligibility Criteria

Sex
ALL
Age
N/A - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • CliniMACS — DEVICE
    Peripheral blood stem cells from closely matched unrelated donors will be processed using the CliniMACS device to remove TCRalpha/beta (alpha beta+) T cells and B cells, in accordance with the Investigator Brochure and Technical Manual following the laboratory standard operating procedures (SOPs) and using aseptic technique

Study Details

Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality. This is a phase I/II study that will test the safety and efficacy of hematopoietic cell transplantation (HCT) with ex-vivo T cell receptor Alpha/Beta+ and CD19 depletion to treat patients' underlying condition. This process is expected to substantially decrease the risk of GvHD thus allowing for the elimination of immunosuppressive therapy post-transplant. The study will use blood stem/progenitor cells collected from the peripheral blood of parent or other half-matched (haploidentical) family member donor. The procedure will be performed using CliniMACS® TCRα/β-Biotin System which is considered investigational.

Key Dates

Start date
Dec 6, 2023
Status verified
Sep 2025
Primary completion
Aug 29, 2024
Completion
May 23, 2026

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Alpha beta+ T cell depleted CD34+ stem cells
    The patient will be receiving a donor stem cell transplant with a preceding conditioning regimen (chemotherapy with, or without, radiation). The investigators will be specially treating the donor's blood cells used for the stem cell transplant.

Primary Outcome Measure

Cumulative Incidence of Neutrophil Engraftment and Platelet Engraftment [ Time Frame: 42 days post-HCT ]

Locations (2)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Houston Methodist Hospital· Houston, TXTexas Children's Hospital· Houston, TX

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