Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
18 participants
INTERVENTIONAL
2026-02-28
2029-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HSC Recipient
PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)
CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)
Interventions
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CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)
* Active fungal infections with radiological and clinical progression
* Liver function abnormalities with bilirubin \>2 mg/dL and elevation of transaminases higher than 400 U/L
* Chronic active viral hepatitis
* Cardiac dysfunction: adult patients ejection fraction \<50% on echocardiography
* Patients with uncontrolled, \>grade II hypertension (per Common Toxicity Criteria, CTC)
* Creatinine clearance \<60 mL/min/1.73m2
* Respiratory failure necessitating supplemental oxygen
* HIV infection
* Positive anti-donor HLA antibody
* Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation
* Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry
* Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study
* Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction).
* Patients unwilling or unable to comply with the protocol or unable to give informed consent
* Treatment with any investigational product within 4 weeks prior to study treatment
18 Years
75 Years
ALL
No
Sponsors
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City of Hope Comprehensive Cancer Center
OTHER
Miltenyi Biomedicine GmbH
INDUSTRY
Responsible Party
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Central Contacts
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Related Links
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A multi-center phase I/II safety and feasibility study using CliniMACS TCRα/β and CD19 depleted stem cell grafts from haploidentical donors for hematopoietic progenitor cell transplantation in children and adults"
Other Identifiers
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M-2018-334
Identifier Type: -
Identifier Source: org_study_id
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