NCT05236764Active, not recruiting
Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion
T-Cell Receptor Alpha Beta+/CD19+ Depletion in Haploidentical Allogeneic Hematopoietic Cell Transplantation (Allo-HCT) for Adult and Pediatric Patients With Hematological Malignancies and Non-malignant Disorders
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 2 Feb 2022
- Start date
- 6 Dec 2023
- Primary completion date
- 29 Aug 2024
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Acute lymphoblastic leukaemia, Chronic myeloid leukaemia, Myelodysplastic syndromes, Chronic lymphocytic leukaemia, Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT05236764
What you commit to
- Study type: Interventional
- Participants enrolled: 3
- From 6 Dec 2023 to the primary completion date, 29 Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Greater than grade II acute graft versus host disease (GVHD) or chronic extensive GVHD due to a previous allograft at the time of inclusion
- Subject receiving an immunosuppressive treatment for GVHD treatment due to a previous allograft at the time of inclusion
- Serious concurrent uncontrolled medical disorder or mental illness
Other illness
- Pre-existing severe restrictive pulmonary disease, FVC \< 40% of predicted
- Current active infectious disease including viral and fungal diseases at the time of enrollment; that on evaluation of PI precludes ablative chemotherapy or successful transplantation
- Active HIV infection
- Severe personality disorder or mental illness that would preclude compliance with the study
Lab values
- Symptomatic cardiac disease or left ventricular shortening fraction less than 25% or ejection fraction \< 40%
- Severe renal disease, with creatinine clearance \< 40cc/1.73m2
- Severe Hepatic Disease with ALT/AST ≥ x 2.5 upper limit of normal or bilirubin level ≥ x 1.5 upper limit of normal
Other
- Life expectancy of less than or equal to 6 weeks
- Pregnant or breastfeeding female subject
Who the study is looking for
- Lack of suitable conventional donor (10/10 HLA matched related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an HLA-matched unrelated donor. This does not include cord blood unit (CBU) availability.
- Lansky/Karnofsky score \> 50
- Signed written informed consent
- Diagnosis of one of the following:
- Patient with life threatening hematological malignancy including "high-risk" ALL in first complete remission (CR1); ALL in second or subsequent remission (greater than or equal to CR2); high-risk AML in CR1; AML in second or subsequent CR; myelodysplastic syndromes (MDS); non-Hodgkin's lymphomas (NHL) in second or subsequent remission (greater than or equal to CR2); CML
- Hemophagocytic Lymphohistiocytosis (HLH) including familial HLH, relapsed HLH or central nervous system (CNS) HLH
- Primary Immunodeficiency Disorders (PID)
- Hemoglobinopathies including thalassemia or sickle cell disease (SCD)
- Severe aplastic anemia (SAA) not responding to immune suppressive therapy
- Congenital/hereditary cytopenias including Fanconi anemia (FA) without malignant clonal evolution (MDA, AML)
- Other inherited bone marrow failure syndromes (IBMFS)
- Sever chronic active Epstein Barr virus infection (SCAEBV) with predilection for T-or NK-cell malignancy
- NOTE: 'High risk' ALL or AML refers to those acute leukemias identified by the presence of specific biologic features, which predict high likelihood of failure to conventional chemotherapy. As biologic features of high-risk disease evolve with improvement of conventional chemotherapy, it is not practical to define this indication with any further specificity. Therefore, high risk AML/ALL will be determined by the primary physician.
Age in the registry: - to 55 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.