Hematologic MalignancyPhase 1NCT05066412
Prophylactic CD45RA-depleted DLI After Haploidentical Transplantation/RIC
A Phase 1 study testing CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology in people with Hematologic Malignancy and Haplo-identical Stem Cell Transplantation, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Haplo-identical Stem Cell Transplantation
- What is being tested?
- CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Nov 2024to 2 Dec 2026
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
- Written informed consent of patient and donor obtained
Who cannot join
- Participant taking Prednisone (or equivalent steroid)
- Participant taking Prednisone (or equivalent steroid)
- Participant taking Mycophenolate Mofetil
- Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
- Progressive hematologic malignancy before transplant
- Second allogeneic transplant
Show all 13Show fewer
- Acute GvHD ≥ grade 2
- Chronic moderate or severe GvHD (NIH consensus criteria)
- Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria)
- Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
- Participation in another interventional clinical trial within 30 days prior to inclusion
- Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion
- Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
HUG
Geneva, Canton of Geneva, 1205
Anne-Claire Mamez, +41795534996, anne-claire.mamez@hcuge.ch
About this study
Official title: A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning
To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.
Read the detailed description
Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning.
Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen.
Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation.
- Being tested
- CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technologyOther
CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Prophylactic CD45RA-depleted DLI Receives: Other: CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute transfusion reaction (CTCAE ≥ 2)
acute transfusion reaction after each DLI infusion (CTCAE ≥ 2)
Measured: 24 hours after each CD45RA neg DLI infusion
acute GvHD grade II-IV
acute GvHD grade II-IV measured with MAGIC score
Measured: within 8 weeks after each CD45RAneg DLI infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start26 Nov 2024
- Primary completion2 Jun 2026 (estimated)
- Study completion2 Dec 2026 (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, GenevaThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Claire Mamez, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066412
- Sponsor's protocol ID
- Cd45RA depleted DLI
- Status last verified
- Jan 2025
- First submitted
- 9 Jul 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning
- ClinicalTrials.gov ID
- NCT05066412
- Acronym / sponsor ID
- Cd45RA depleted DLI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 2 Jun 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 4 Oct 2021 (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.
To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.
Detailed description
Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning.
Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen.
Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technologyProphylactic CD45RA-depleted DLI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
- Written informed consent of patient and donor obtained
Key exclusion criteria (13 listed)
- Participant taking Prednisone (or equivalent steroid)
- Participant taking Prednisone (or equivalent steroid)
- Participant taking Mycophenolate Mofetil
- Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
- Progressive hematologic malignancy before transplant
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 |
|---|---|---|
| CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technologyCD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology | Other | Arm 1 |
Primary outcome
acute transfusion reaction (CTCAE ≥ 2)
Time frame: 24 hours after each CD45RA neg DLI infusion
acute transfusion reaction after each DLI infusion (CTCAE ≥ 2)
acute GvHD grade II-IV
Time frame: within 8 weeks after each CD45RAneg DLI infusion
acute GvHD grade II-IV measured with MAGIC score
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 13 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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 Phase 1 study testing CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology in people with Hematologic Malignancy and Haplo-identical Stem Cell Transplantation, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 inclusion and 13 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 13 Feb 2025. 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 Switzerland. 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 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.
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 Anne-Claire Mamez (+41786656487, anne-claire.mamez@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute transfusion reaction (CTCAE ≥ 2) (time frame: 24 hours after each CD45RA neg DLI infusion). 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 13 Feb 2025.