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

NCT05236764 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-10-30

Study results available
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Summary

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.

Conditions

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

Interventions

DEVICE

CliniMACS

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

Sponsors & Collaborators

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Erin Morales, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2024-08-29
Completion
2026-05-23
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05236764 on ClinicalTrials.gov