Recruiting

TCRα/β & CD45RAM-2018-334 in Hematological Malignancies

Sponsor:

Miltenyi Biomedicine GmbH

Code:

NCT06225050

Conditions

Hematological Malignancies

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)

Study Details

Brief summary:

This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.

Conditions

Hematological Malignancies

Study ID

NCT06225050

Start date

Aug 21, 2026

Status verified date

Sep, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available

Exclusion Criteria:

<3 months after preceding autologous transplantation or prior AlloHCT
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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HSC Recipient

PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)

Interventions

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)

Primary outcome measure

Incidence of severe acute GVHD (aGVHD) till Day 100 [ Time Frame: 100 days after haploidentical hematopoietic cell transplantation ]

Central Contacts and Locations

Central contacts

Clinical Trial Manager

+49 22048306820 clinicaltrials.gov@miltenyi.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

More Information

Sponsor

Miltenyi Biomedicine GmbH

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Miltenyi Biomedicine GmbH on 2026-09-11.