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NCT Number: NCT06225050

M-2018-334 in Hematological Malignancies

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.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Incidence of severe acute GVHD (aGVHD) till Day 100

    Time frame: 100 days after haploidentical hematopoietic cell transplantation

    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.

Secondary outcomes

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

    Time frame: Until Last Patient Last Visit(24 Months)

    Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) will be assessed by calculating the log-depletion of TCRα/β+ and CD45RA+ cells

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

    Time frame: 6 Months

    Incidence of aGVHD, grade II-IV till six months post-transplantation will be evaluated. The maximum grade and the time to occurrence of acute GVHD will be recorded. Incidence and severity of acute GVHD will be graded according to the Consensus Criteria

  3. Neutrophil Engraftment

    Time frame: Day 7

    Time to neutrophil engraftment will be defined as the first of three consecutive measurements of ANC ≥500/µL following conditioning regimen induced nadir, starting from the day of the first stem cell transplantation

  4. Platelet Engraftment

    Time frame: Day 0

    Time to platelet engraftment will be defined as the first of three consecutive measurements of platelet count ≥20,000/µL without platelet transfusion support, starting from the day of the first stem cell transplantation.

  5. Chronic GVHD

    Time frame: 1 Year

    Incidence and severity of chronic GVHD will be graded according to standard criteria for grading of chronic GVHD

  6. Non-relapse mortality (NRM)

    Time frame: Until Last patient last Visit(24 Months)

    NRM is defined as death occurring in a patient between the first day of conditioning and day of last assessment (all visits throughout the study), not due to disease relapse/recurrence

  7. Infusion toxicity

    Time frame: 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion

    Maximum infusion toxicity on the days of transfusion will be evaluated by measuring the patient's blood pressure, heart rate, respiration rate and temperature one hour prior to the allograft infusion and then approximately 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion

  8. Graft failure

    Time frame: 30 Days

    Primary graft failure is defined as the failure to achieve an ANC ≥500 cells/µL by Day +30 in the setting of donor chimerism < 5% using local methods

  9. Overall survival (OS)

    Time frame: Day 100 and through study completion, an average of 1 year post transplantation

    OS defined as time from transplantation to death or last follow-up and will be assessed at Day 100 and after 1 year

  10. Disease-free survival (DFS)

    Time frame: Day 100 and through study completion, an average of 1 year post transplantation

    DFS is defined as the minimum time to relapse/recurrence, to death or to the last follow-up, from the time of transplantation and will be assessed at Day 100 and after 1 year

  11. GVHD/relapse-free survival (GRFS)

    Time frame: GRFS will be assessed at Month 12 post transplantation

    An event is defined as grade III-IV acute GVHD, moderate to severe chronic GVHD, disease relapse, or death by any cause. GRFS will be assessed at 1 year.

  12. Immunosuppression-free survival (ISFS)

    Time frame: Assessed at 1 year with a starting point at Day 45 post-transplantation

    Defined as being alive, relapse-free and off immunosuppressive therapy and will be assessed at 1 year with a starting point at Day 45 post-transplantation. Immune suppression is defined as any systemic agents used to control or suppress GVHD.

  13. Relapse rate

    Time frame: 12 Months

    Time to relapse will be calculated from the time of transplantation to evidence of relapse

  14. Hospitalization length/re-admission

    Time frame: Assessed at Day 30, Day 100 and at 12 Months post transplantation

    Number of days that patients had to be hospitalized until discharge after transplantation, and after any subsequent occurrence of an event leading to re- hospitalization assessed

Study contacts

Contact information is provided by the study sponsor or research team.

Premchand Pastula

CONTACT

[email protected]

+49 15144059503

Sponsors and collaborators

Lead sponsor

Miltenyi Biomedicine GmbH

Industry

Collaborators

  • City of Hope Medical Center

Registry information

Official study title

A Single-center Pilot Study Using TCRα/β and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults(HAPLO2022)

Acronym: HAPLO2022

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jan 25, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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