Hematologic MalignancyPhase 1CD45RADLIPxNCT07672964
CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation
A Phase 1 study testing CD45RA-depleted DLI in people with Hematologic Malignancy and Haplo-identical HCT, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether giving patients a special type of donor immune cells (called CD45RA Depleted DLI) can help prevent viral infections after a stem cell transplant. It will also learn about the safety of this treatment. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Hematologic Malignancy, Haplo-identical HCT
- What is being tested?
- CD45RA-depleted DLI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Jul 2028
- 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 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Patients undergoing allogeneic hematopoietic stem cell transplantation (any conditioning regimen or graft source is allowed).
- Presence of at least one high-risk factor for post-transplant viral infection (any of the following):
- Age ≥50 years or ≤14 years
- Non-sibling matched transplantation
- In vivo or ex vivo T-cell depletion
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- Myeloablative conditioning
- Conditioning containing radiotherapy
- Second transplantation
- CMV IgG or EBV IgG donor/recipient mismatch (donor positive, recipient negative)
- History of grade II or higher acute graft-versus-host disease (aGVHD) after transplantation and use of high-dose corticosteroids (prednisone equivalent ≥1 mg/kg/day)
- Availability of a suitable lymphocyte donor (see "Donor Selection Criteria").
- Adequate organ function meeting the following laboratory criteria:
- Liver function: ALT and AST ≤10× upper limit of normal (ULN); total bilirubin ≤5× ULN
- Renal function: BUN and creatinine ≤1.25× ULN
- No cardiac dysfunction on electrocardiogram or echocardiogram
- Pulmonary function: oxygen saturation >90% without supplemental oxygen
- The patient or legal guardian has the desire and request to receive treatment, signs the informed consent form before treatment, and is willing to comply with the treatment plan, follow-up schedule, and laboratory tests.
Who cannot join
- Patients meeting any of the following criteria will be excluded from this study:
- Active grade II-IV acute graft-versus-host disease (aGVHD)
- Active aGVHD requiring prednisone or equivalent corticosteroid >0.5 mg/kg/day
- Active viral infection
- Uncontrolled or relapsed malignancy
- Other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or affect informed consent, study participation, follow-up, or interpretation of results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital
Shanghai, SH, 200025
Xiaoxia Hu, MD, PhD, 008613795437259, hu_xiaoxia@126.com
About this study
Official title: CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Transplantation: a Prospective, Multicenter, Single-arm, Pragmatic Clinical Study
The goal of this clinical trial is to learn whether giving patients a special type of donor immune cells (called CD45RA Depleted DLI) can help prevent viral infections after a stem cell transplant. It will also learn about the safety of this treatment. The main questions it aims to answer are:
Does this treatment lower the chance of getting serious viral infections after transplant? What medical problems do patients have when receiving this treatment?
Read the detailed description
Following allogeneic hematopoietic stem cell transplantation (allo-HSCT), delayed immune reconstitution and long-term use of immunosuppressants leave patients in a prolonged immunocompromised state, predisposing them to various infections, which represent a leading cause of transplant-related mortality. Conventional antiviral agents such as ganciclovir and valganciclovir are associated with hematologic toxicities, including neutropenia and anemia, potentially complicating post-transplant management. Meanwhile, newer antivirals such as cidofovir have not yet been approved in China, limiting patient access. Antiviral cell therapies, represented by virus-specific T cells (VSTs), are expensive and require prolonged culture periods. Therefore, there is an urgent need to identify effective strategies to prevent viral infections after HSCT, especially in high-risk patients.
Previous studies suggest that adoptive donor lymphocyte infusion (DLI) can facilitate immune reconstitution; however, the CD45RA-positive naïve T cells contained in conventional DLI are a major cause of graft-versus-host disease (GvHD). By depleting naïve T cells from donor lymphocytes ex vivo while retaining donor memory T cells (Tm), it is possible to promote post-transplant immune reconstitution without increasing the risk of GvHD. This study plans to conduct a prospective, multicenter, single-arm pragmatic clinical trial. Using the CliniMACS® cell selection system, we will selectively deplete CD45RA-positive T cells ex vivo and infuse the CD45RA-depleted donor lymphocytes (i.e., CD45RA Depleted DLI) to prevent viral infections in high-risk patients after transplantation. The efficacy, safety, and impact on post-transplant immune reconstitution of this regimen will be evaluated.
Primary objective: To evaluate the efficacy and safety of CD45RA Depleted DLI in preventing viral infections in high-risk patients after transplantation.
Secondary objective: To evaluate the impact of CD45RA Depleted DLI on immune reconstitution after transplantation.
- Conditions
- Hematologic Malignancy, Haplo-identical HCT
- Being tested
- CD45RA-depleted DLI
- Keywords
- CD45RA, 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 DLIBiological
CD45RA Depleted DLI by ex vivo CliniMACS® prepared from mononuclear cell leukapheresis
| Study group | Role | What they receive |
|---|---|---|
| Prevention Group | Experimental | Prophylactic CD45RA-depleted DLI Receives: Biological: CD45RA-depleted DLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Overall Viral Infection After CD45RA-Depleted DLI
Overall viral infection is defined as the first occurrence of any qualifying viral infection or reactivation detected by quantitative PCR after the first CD45RA-DLI infusion. Viruses assessed include CMV, EBV, ADV, BKV, HHV6, JCV, and B19.
A participant will be considered to have a qualifying viral event if any of the following thresholds are met: CMV DNA ≥250 IU/mL, EBV DNA ≥250 IU/mL, ADV DNA ≥1,000 copies/mL, BKV DNA ≥5,000 copies/mL, HHV6 DNA ≥1,000 copies/mL, JCV DNA ≥1,000 copies/mL, or B19 DNA ≥1,000 copies/mL.
The outcome will be reported as the cumulative incidence, expressed as the percentage of participants with at least one qualifying viral infection or reactivation event during the assessment period.
Measured: Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.
Secondary outcomes (3)
Cumulative Incidence of Virus-Specific Infections After CD45RA-Depleted DLI
Report cumulative incidence separately for CMV, EBV, ADV, BKV, HHV6, JCV, and B19 using the protocol-defined PCR thresholds.
Measured: Up to 3 months after first infusion
Absolute Counts of Peripheral Blood Lymphocyte Subsets as Measured by Flow Cytometry
Immune reconstitution will be assessed by flow cytometric enumeration of peripheral blood lymphocyte subsets, including CD3+ T cells, CD4+ T cells, CD8+ T cells, CD19+ B cells, CD56+ NK cells, and CD4+CD25+CD127- regulatory T cells.
Measured: Up to 1 year after the first CD45RA-depleted DLI
Virus-Specific T-Cell Immune Responses After CD45RA-Depleted DLI
Virus-specific immune reconstitution will be assessed by measuring virus-specific T-cell responses against CMV, EBV, ADV, BKV, B19, HHV6, and JCV using the protocol-defined virus-specific T-cell assay.
Measured: Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 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 Ruijin HospitalThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Liquan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672964
- Sponsor's protocol ID
- RJ-BMT-Prophylaxis 1.0
- Acronym
- CD45RADLIPx
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcome data will be shared via request after publication of results.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Transplantation: a Prospective, Multicenter, Single-arm, Pragmatic Clinical Study
- ClinicalTrials.gov ID
- NCT07672964
- Acronym / sponsor ID
- CD45RADLIPx / RJ-BMT-Prophylaxis 1.0
- Conditions
- Hematologic Malignancy, Haplo-identical HCT
- Keywords
- CD45RA, DLI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Liquan Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 Jun 2026 (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 goal of this clinical trial is to learn whether giving patients a special type of donor immune cells (called CD45RA Depleted DLI) can help prevent viral infections after a stem cell transplant. It will also learn about the safety of this treatment. The main questions it aims to answer are:
Does this treatment lower the chance of getting serious viral infections after transplant? What medical problems do patients have when receiving this treatment?
Detailed description
Following allogeneic hematopoietic stem cell transplantation (allo-HSCT), delayed immune reconstitution and long-term use of immunosuppressants leave patients in a prolonged immunocompromised state, predisposing them to various infections, which represent a leading cause of transplant-related mortality. Conventional antiviral agents such as ganciclovir and valganciclovir are associated with hematologic toxicities, including neutropenia and anemia, potentially complicating post-transplant management. Meanwhile, newer antivirals such as cidofovir have not yet been approved in China, limiting patient access. Antiviral cell therapies, represented by virus-specific T cells (VSTs), are expensive and require prolonged culture periods. Therefore, there is an urgent need to identify effective strategies to prevent viral infections after HSCT, especially in high-risk patients.
Previous studies suggest that adoptive donor lymphocyte infusion (DLI) can facilitate immune reconstitution; however, the CD45RA-positive naïve T cells contained in conventional DLI are a major cause of graft-versus-host disease (GvHD). By depleting naïve T cells from donor lymphocytes ex vivo while retaining donor memory T cells (Tm), it is possible to promote post-transplant immune reconstitution without increasing the risk of GvHD. This study plans to conduct a prospective, multicenter, single-arm pragmatic clinical trial. Using the CliniMACS® cell selection system, we will selectively deplete CD45RA-positive T cells ex vivo and infuse the CD45RA-depleted donor lymphocytes (i.e., CD45RA Depleted DLI) to prevent viral infections in high-risk patients after transplantation. The efficacy, safety, and impact on post-transplant immune reconstitution of this regimen will be evaluated.
Primary objective: To evaluate the efficacy and safety of CD45RA Depleted DLI in preventing viral infections in high-risk patients after transplantation.
Secondary objective: To evaluate the impact of CD45RA Depleted DLI on immune reconstitution after transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention Group | Experimental | Biological: CD45RA-depleted DLIProphylactic CD45RA-depleted DLI |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (18 listed)
- Patients undergoing allogeneic hematopoietic stem cell transplantation (any conditioning regimen or graft source is allowed).
- Presence of at least one high-risk factor for post-transplant viral infection (any of the following):
- Age ≥50 years or ≤14 years
- Non-sibling matched transplantation
- In vivo or ex vivo T-cell depletion
Key exclusion criteria (6 listed)
- Active grade II-IV acute graft-versus-host disease (aGVHD)
- Active aGVHD requiring prednisone or equivalent corticosteroid >0.5 mg/kg/day
- Active viral infection
- Uncontrolled or relapsed malignancy
- Other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or affect informed consent, study participation, follow-up, or interpretation of results.
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 DLICD45RA Depleted DLI by ex vivo CliniMACS® prepared from mononuclear cell leukapheresis | Biological | Prevention Group |
Primary outcome
Cumulative Incidence of Overall Viral Infection After CD45RA-Depleted DLI
Time frame: Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.
Overall viral infection is defined as the first occurrence of any qualifying viral infection or reactivation detected by quantitative PCR after the first CD45RA-DLI infusion. Viruses assessed include CMV, EBV, ADV, BKV, HHV6, JCV, and B19. A participant will be considered to have a qualifying viral event if any of the following thresholds are met: CMV DNA ≥250 IU/mL, EBV DNA ≥250 IU/mL, ADV DNA ≥1,000 copies/mL, BKV DNA ≥5,000 copies/mL, HHV6 DNA ≥1,000 copies/mL, JCV DNA ≥1,000 copies/mL, or B19 DNA ≥1,000 copies/mL. The outcome will be reported as the cumulative incidence, expressed as the percentage of participants with at least one qualifying viral infection or reactivation event during the assessment period.
3 secondary outcomes
Cumulative Incidence of Virus-Specific Infections After CD45RA-Depleted DLI
Time frame: Up to 3 months after first infusion
Absolute Counts of Peripheral Blood Lymphocyte Subsets as Measured by Flow Cytometry
Time frame: Up to 1 year after the first CD45RA-depleted DLI
Virus-Specific T-Cell Immune Responses After CD45RA-Depleted DLI
Time frame: Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.
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 29 Jun 2026.
- Individual participant dataSharing planned: Yes. Outcome data will be shared via request after publication of results.
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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 Phase 1 study testing CD45RA-depleted DLI in people with Hematologic Malignancy and Haplo-identical HCT, run by Ruijin Hospital at 1 site in China.
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 18 inclusion and 6 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: opening soon, as of the sponsor's last update on 29 Jun 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 China. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Overall Viral Infection After CD45RA-Depleted DLI (time frame: Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.). 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 29 Jun 2026.