Hematological MalignanciesHAPLO2022NCT06225050
M-2018-334 in Hematological Malignancies
A study testing CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) in people with Hematological Malignancies, run by Miltenyi Biomedicine GmbH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- <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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
About this study
Official 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)
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
- Being tested
- CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 100 days after haploidentical hematopoietic cell transplantation
Secondary outcomes (14)
Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version)
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
Measured: Until Last Patient Last Visit(24 Months)
Incidence of acute GVHD (aGVHD) till six months post-transplantation
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
Measured: 6 Months
Neutrophil Engraftment
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
Measured: Day 7
Platelet Engraftment
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.
Measured: Day 0
Chronic GVHD
Incidence and severity of chronic GVHD will be graded according to standard criteria for grading of chronic GVHD
Measured: 1 Year
Non-relapse mortality (NRM)
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
Measured: Until Last patient last Visit(24 Months)
Infusion toxicity
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
Measured: 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion
Graft failure
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
Measured: 30 Days
Overall survival (OS)
OS defined as time from transplantation to death or last follow-up and will be assessed at Day 100 and after 1 year
Measured: Day 100 and through study completion, an average of 1 year post transplantation
Disease-free survival (DFS)
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
Measured: Day 100 and through study completion, an average of 1 year post transplantation
GVHD/relapse-free survival (GRFS)
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.
Measured: GRFS will be assessed at Month 12 post transplantation
Immunosuppression-free survival (ISFS)
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.
Measured: Assessed at 1 year with a starting point at Day 45 post-transplantation
Relapse rate
Time to relapse will be calculated from the time of transplantation to evidence of relapse
Measured: 12 Months
Hospitalization length/re-admission
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
Measured: Assessed at Day 30, Day 100 and at 12 Months post transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start21 Aug 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biomedicine GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- City of Hope Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225050
- Sponsor's protocol ID
- M-2018-334
- Acronym
- HAPLO2022
- Status last verified
- Sep 2026
- First submitted
- 5 Dec 2023
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06225050
- Acronym / sponsor ID
- HAPLO2022 / M-2018-334
- Conditions
- Hematological Malignancies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Miltenyi Biomedicine GmbHIndustry (pharma, biotech, devices)
- Collaborators
- City of Hope Medical Center
- Study start
- 21 Aug 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSC Recipient | Experimental | Device: 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (17 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | HSC Recipient |
Primary outcome
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.
14 secondary outcomes
Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version)
Time frame: Until Last Patient Last Visit(24 Months)
Incidence of acute GVHD (aGVHD) till six months post-transplantation
Time frame: 6 Months
Neutrophil Engraftment
Time frame: Day 7
Platelet Engraftment
Time frame: Day 0
Chronic GVHD
Time frame: 1 Year
Non-relapse mortality (NRM)
Time frame: Until Last patient last Visit(24 Months)
Infusion toxicity
Time frame: 15 minutes, 30 minutes, 2 hours, and 4 hours post infusion
Graft failure
Time frame: 30 Days
Overall survival (OS)
Time frame: Day 100 and through study completion, an average of 1 year post transplantation
Disease-free survival (DFS)
Time frame: Day 100 and through study completion, an average of 1 year post transplantation
GVHD/relapse-free survival (GRFS)
Time frame: GRFS will be assessed at Month 12 post transplantation
Immunosuppression-free survival (ISFS)
Time frame: Assessed at 1 year with a starting point at Day 45 post-transplantation
Relapse rate
Time frame: 12 Months
Hospitalization length/re-admission
Time frame: Assessed at Day 30, Day 100 and at 12 Months post transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- 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"Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) in people with Hematological Malignancies, run by Miltenyi Biomedicine GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Manager (+49 22048306820, clinicaltrials.gov@miltenyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe acute GVHD (aGVHD) till Day 100 (time frame: 100 days after haploidentical hematopoietic cell transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.