NCT06225050

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
35mo left

Started Feb 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Feb 2026Feb 2029

First Submitted

Initial submission to the registry

December 5, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
2.1 years until next milestone

Study Start

First participant enrolled

February 28, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

3 years

First QC Date

December 5, 2023

Last Update Submit

November 25, 2025

Conditions

Hematological Malignancies

Outcome Measures

Primary Outcomes (1)

  • Incidence of severe acute GVHD (aGVHD) till Day 100

    Participants will be evaluated for the occurrence of aGVHD, grades III-IV in the first 100 days after transplantation and the time to occurrence of aGVHD, grades III-IV will be recorded. Severity of acute GVHD will be graded according to the CONSENSUS CRITERIA FOR GRADING OF ACUTE GVHD which has four Grades from Grade I to Grade IV. The higher the Score, the Worse the outcome.

    100 days after haploidentical hematopoietic cell transplantation

Secondary Outcomes (14)

  • Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version)

    Until Last Patient Last Visit(24 Months)

  • Incidence of acute GVHD (aGVHD) till six months post-transplantation

    6 Months

  • Neutrophil Engraftment

    Day 7

  • Platelet Engraftment

    Day 0

  • Chronic GVHD

    1 Year

  • +9 more secondary outcomes

Study Arms (1)

HSC Recipient

EXPERIMENTAL

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

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

Interventions

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

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

HSC Recipient

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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).
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Premchand Pastula

CONTACT

+49 15144059503clinicaltrials_gov_ClinDev@miltenyibiotec.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2023

First Posted

January 25, 2024

Study Start

February 28, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

December 3, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share