Hematologic MalignancyPhase 1/2CD45RADLIHaploNCT05943067
CD45RA Depleted DLI After TCRα/β Depleted Haploidentical HCT
A Phase 1/2 study testing CD45RA depleted donor lymphocyte infusion (DLI) in people with Hematologic Malignancy, run by University Hospital Tuebingen at 2 sites in Germany.
Trial summary
The purpose of this clinical trial is to examine safety and toxicity of CD45RA depleted donor lymphocyte infusion (DLI) after transplantation of TCRα/β/CD19 depleted peripheral blood stem cells. Read more about this study
- Who is it for?
- Ages 8 weeks to 65 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- CD45RA depleted donor lymphocyte infusion (DLI)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- 27 Apr 2023to Dec 2028
- Phase
- Phase 1/2
- 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 8 weeks to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult and pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
- Acute myeloid leukemia (AML):
- Patients with high-risk AML in first complete remission (CR1)
- Patients with relapsed or primary therapy-refractory AML
- Acute lymphoid leukemia (ALL):
- Patients with high-risk ALL in CR1
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- Patients with relapsed or primary refractory ALL
- Hodgkin's disease: Patients with relapsed or primary refractory Hodgkin's disease
- Non-Hodgkin's lymphoma: Patients with relapsed or primary refractory Non- Hodgkin's lymphoma
- Myelodysplastic Syndrome (MDS)/ Myeloproliferative Syndrome (MPS):
- °Patients with refractory MDS/MPS
- Multiple myeloma (MM): Patients with relapsed or refractory multiple myeloma
Who cannot join
- Age >65 years or <8 weeks
- Patients with progressive disease prior hematopoietic cell transplantation (HCT)
- <3 months after preceding HCT
- Treatment with T-cell or Interleukin-2 (IL-2) targeted medication (e.g. alemtuzumab, basiliximab) within 60 days prior to study product infusion
- Treatment with prednisolone at >2 mg/kg/day (or equivalent dosing of alternative glucocorticosteroids) at time of study product infusion.
- Known allergy/hypersensitivity to any component of the study product
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- Treatment with another investigational drug within one month before inclusion
- History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active Central Nervous System (CNS) infection) Note: For patients with heavy pretreatment with irradiation or intrathecal chemotherapy pre-transplant CNS MRI and neurological consultation are mandatory.
- 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
- Ejection fraction <40% or Shortening fraction <20% on echocardiography. Patients with > grade II hypertension by Common Toxicity Criteria (CTC)
- Creatinine clearance below threshold defined for stem cell transplantation according to local clinical standard
- Respiratory failure necessitating supplemental oxygen
- HIV infection
- 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, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
University Children's Hospital University Clinic Tuebingen
Tübingen, 72076
Peter Lang, MD, PhD, +49 7071 29-81386, peter.lang@med.uni-tuebingen.de
Michaela Döring, MD, PhD, +49 7071 29-81386, michaela.doering@med.uni-tuebingen.de
- Recruiting
University Hospital Tuebingen, Department of Hematology, Oncology, Immunology and Rheumatology
Tübingen, 72076
Wolfgang Bethge, MD, PhD, +49 (0) 7071 29-83176, wolfgang.bethge@med.uni-tuebingen.de
Christoph Faul, MD, PhD, +49 (0) 7071 29-84087, christoph.faul@med.uni-tuebingen.de
About this study
Official title: A Multi-center Phase I/II Trial of Memory T Cell Donor Lymphocyte Infusions After Transplantation of CliniMACS® TCRα/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation
The purpose of this clinical trial is to examine safety and toxicity of CD45RA depleted donor lymphocyte infusion (DLI) after transplantation of TCRα/β/CD19 depleted peripheral blood stem cells.
Read the detailed description
Patients will undergo routine reduced intensity conditioning regimen and intravenous infusion of T-cell receptor alpha/beta (TCRα/β)/CD19 depleted peripheral blood stem cells (not content of clinical trial).
If no graft-versus-host disease (GVHD) occurs, patients receive the trial-related memory T cell donor lymphocyte infusion (DLI) on Day 30 after transplantation.
In a dose finding part (phase I) escalating doses will be applied in cohorts of three (three plus three design) patients with a maximum of 18 patients for three dose levels (dose level 1-3). A fourth lower dose level (dose level 0) is started, if >=2 out of 6 patients with dose level 1 develop aGVHD III/IV. The maximum tolerated dose (MTD) will be used for the confirmatory part (phase II) of the study.
- Conditions
- Hematologic Malignancy
- Being tested
- CD45RA depleted donor lymphocyte infusion (DLI)
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD45RA depleted donor lymphocyte infusion (DLI)Biological
CD45RA depleted donor lymphocyte infusion (DLI) after TCRα/β depleted haploidentical HCT
| Study group | Role | What they receive |
|---|---|---|
| Single-arm | Other | Donor lymphocytes from allogeneic donors depleted of CD45RA lymphocytes. Receives: Biological: CD45RA depleted donor lymphocyte infusion (DLI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I, dose escalation
Safety and toxicity of CD45RA depleted DLI as defined by infusional toxicities and acute GVHD grad III-IV.
Measured: 100 days
Phase II, extension phase
Acute graft-versus-host disease grade III-IV defined as GVHD occurring within 100 days after HCT
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start27 Apr 2023
- Primary completionJan 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943067
- Sponsor's protocol ID
- CD45RADLIHaplo
- Acronym
- CD45RADLIHaplo
- Status last verified
- Apr 2025
- First submitted
- 4 Jul 2023
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Phase I/II Trial of Memory T Cell Donor Lymphocyte Infusions After Transplantation of CliniMACS® TCRα/β and CD19 Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT05943067
- Acronym / sponsor ID
- CD45RADLIHaplo / CD45RADLIHaplo
- Conditions
- Hematologic Malignancy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 13 Jul 2023 (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.
The purpose of this clinical trial is to examine safety and toxicity of CD45RA depleted donor lymphocyte infusion (DLI) after transplantation of TCRα/β/CD19 depleted peripheral blood stem cells.
Detailed description
Patients will undergo routine reduced intensity conditioning regimen and intravenous infusion of T-cell receptor alpha/beta (TCRα/β)/CD19 depleted peripheral blood stem cells (not content of clinical trial).
If no graft-versus-host disease (GVHD) occurs, patients receive the trial-related memory T cell donor lymphocyte infusion (DLI) on Day 30 after transplantation.
In a dose finding part (phase I) escalating doses will be applied in cohorts of three (three plus three design) patients with a maximum of 18 patients for three dose levels (dose level 1-3). A fourth lower dose level (dose level 0) is started, if >=2 out of 6 patients with dose level 1 develop aGVHD III/IV. The maximum tolerated dose (MTD) will be used for the confirmatory part (phase II) of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Other | Biological: CD45RA depleted donor lymphocyte infusion (DLI)Donor lymphocytes from allogeneic donors depleted of CD45RA lymphocytes. |
Who may qualify
- Ages
- 8 weeks to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Adult and pediatric patients with hematological malignancies in complete remission (CR), partial remission (PR) or with stable disease
- Acute myeloid leukemia (AML):
- Acute lymphoid leukemia (ALL):
- Hodgkin's disease: Patients with relapsed or primary refractory Hodgkin's disease
- Non-Hodgkin's lymphoma: Patients with relapsed or primary refractory Non- Hodgkin's lymphoma
Key exclusion criteria (19 listed)
- Age >65 years or <8 weeks
- Patients with progressive disease prior hematopoietic cell transplantation (HCT)
- <3 months after preceding HCT
- Treatment with T-cell or Interleukin-2 (IL-2) targeted medication (e.g. alemtuzumab, basiliximab) within 60 days prior to study product infusion
- Treatment with prednisolone at >2 mg/kg/day (or equivalent dosing of alternative glucocorticosteroids) at time of study product infusion.
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 |
|---|---|---|
| CD45RA depleted donor lymphocyte infusion (DLI)CD45RA depleted donor lymphocyte infusion (DLI) after TCRα/β depleted haploidentical HCT | Biological | Single-arm |
Primary outcome
Phase I, dose escalation
Time frame: 100 days
Safety and toxicity of CD45RA depleted DLI as defined by infusional toxicities and acute GVHD grad III-IV.
Phase II, extension phase
Time frame: 100 days
Acute graft-versus-host disease grade III-IV defined as GVHD occurring within 100 days after HCT
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 27 Apr 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD45RA depleted donor lymphocyte infusion (DLI) in people with Hematologic Malignancy, run by University Hospital Tuebingen at 2 sites in Germany.
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 12 inclusion and 19 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 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Wolfgang Bethge, MD, PhD (+49 7071 29-83176, wolfgang.bethge@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I, dose escalation (time frame: 100 days). The study lists 2 primary outcomes in all. 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 27 Apr 2025.