Hematologic MalignancyPhase 1/2CD45RADLITxNCT07662369
CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Haploidentical Transplantation
A Phase 1/2 study testing CD45RA depleted donor lymphocyte infusion (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 special donor immune cells (called "CD45RA Depleted DLI") can help treat viral infections that have not improved with standard antiviral drugs. These infections occur after a stem cell transplant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Malignancy, Haplo-identical HCT
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to 30 Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Patients who have undergone hematopoietic stem cell transplantation.
- Presence of viremia and/or viral infection-related disease caused by a single virus or multiple viruses among the following: CMV, EBV, ADV, BK, B19, JC, HHV-6B, HSV1, or HSV2.
- Patients who, after ≥2 weeks of first-line therapy, have persistent viral positivity, no relief or worsening of clinical symptoms, or re-infection with the same pathogen after viral clearance.
- Availability of a suitable lymphocyte donor.
- Adequate organ function, meeting the following laboratory criteria:
Show all 11Show fewer
- Liver function: ALT and AST ≤ 10 × upper limit of normal (ULN), TBIL ≤ 5 × ULN.
- Renal function: BUN and Cr ≤ 1.25 × ULN.
- No cardiac insufficiency on electrocardiogram (ECG) or echocardiogram.
- Pulmonary function: oxygen saturation > 90% on room air.
- Willingness and ability of the patient or their legal guardian to receive treatment, comply with the treatment plan, follow-up schedule, and laboratory examinations, and provision of signed informed consent before any study-specific procedure.
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).
- Prednisone or equivalent corticosteroid dose > 0.5 mg/kg/day.
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab (Campath), or other T-cell immunosuppressive monoclonal antibodies within 28 days before enrollment.
- Less than 28 days after allogeneic transplantation, or receipt of donor lymphocyte infusion (DLI) or virus-specific T cell (VST) therapy within 28 days before enrollment.
- Uncontrolled or relapsed malignancy.
- Presence of other serious acute or chronic physical or psychiatric conditions, or laboratory abnormalities, that may compromise patient safety or compliance, or that may interfere with informed consent, study participation, follow-up, or interpretation of study 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, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, SH, 200025
Xiaoxia Hu, MD, PhD, 008613795437259, hu_xiaoxia@126.com
About this study
Official title: Ex Vivo CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Transplantation: a Prospective, Multicenter, Single-arm, Pragmatic Clinical Study
The goal of this clinical trial is to learn whether giving patients special donor immune cells (called "CD45RA Depleted DLI") can help treat viral infections that have not improved with standard antiviral drugs. These infections occur after a stem cell transplant. The study will also look at the safety of this treatment.
Read the detailed description
Due to delayed immune reconstitution and long-term use of immunosuppressants after allogeneic hematopoietic stem cell transplantation, patients remain in a state of prolonged immunocompromise and are prone to various infections, which is one of the leading causes of death after transplantation. The overall response rate of various antiviral drugs ranges from 60% to 80%, meaning 20-40% of patients cannot be effectively treated. Moreover, most antiviral agents have significant toxicities that patients often cannot tolerate. Therefore, finding appropriate and effective antiviral therapeutic strategies is urgently needed for transplant recipients.
Previous studies have indicated that adoptive donor lymphocyte infusion (DLI) can help reconstitute immunity; however, the CD45RA-positive naïve T cells contained in DLI are a major cause of graft-versus-host disease (GVHD). By ex vivo selection to deplete naïve T cells from donor lymphocytes while retaining donor memory T cells (Tm), it may be possible to promote immune reconstitution, clear viral infections, improve the cure rate of viral infections, and reduce the incidence of GVHD. This study is planned as a prospective, multicenter, single-arm, pragmatic clinical trial. We intend to use the CliniMACS® cell selection system to selectively deplete CD45RA-positive T cells ex vivo and infuse the selected donor lymphocytes (DLI) to treat viral infections that are refractory to first-line therapy after hematopoietic stem cell transplantation. We will evaluate the efficacy and safety of this treatment for post-transplant viral infections, as well as its impact on immune reconstitution after transplantation.
Study Objectives:
Primary objective: To evaluate the efficacy and safety of CD45RA Depleted DLI for the treatment of refractory/persistent viral infections after transplantation.
Secondary objective: To evaluate the effect of CD45RA Depleted DLI on the reconstitution of virus-specific T cell (VST) immunity after transplantation.
- Conditions
- Hematologic Malignancy, Haplo-identical HCT
- Being tested
- CD45RA depleted donor lymphocyte infusion (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 donor lymphocyte infusion (DLI)Biological
CD45RA depleted donor lymphocyte infusion (DLI) admission with escalated dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | CD45RA Depleted DLI 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.
Percentage of Participants Achieving Overall Response of Viral Infection Based on Quantitative PCR and Clinical Response Criteria
Overall response rate is defined as the percentage of participants who achieve complete response or partial response after CD45RA-depleted DLI.
Complete response is defined as negative viral PCR together with disappearance of all virus-related clinical signs and symptoms.
Partial response is defined as at least a 50% reduction in viral load from baseline together with at least 1-grade improvement in clinical symptoms.
Overall response rate will be calculated as the number of participants with complete response or partial response divided by the total number of evaluable participants.
Measured: 90 days after the first CD45RA-depleted donor lymphocyte infusion
Secondary outcomes (3)
Virus-specific T-cell Response
Virus-specific T-cell response will be assessed in peripheral blood using the protocol-specified virus-specific T-cell assay. The assessment may include virus-specific T-cell responses against clinically relevant protocol-specified viruses, including CMV, EBV, adenovirus, BK virus, B19, HHV-6, and JC virus, as applicable to each participant's viral infection. The outcome will summarize the change from baseline in virus-specific T-cell response after CD45RA-depleted DLI.
Measured: 90 days after the first CD45RA-depleted DLI
Grade III-IV Acute Graft-versus-Host Disease
This outcome will measure the percentage of participants who develop new-onset Grade III-IV acute graft-versus-host disease after CD45RA-depleted DLI. Acute GVHD will be assessed and graded according to MAGIC criteria.
Measured: 90 days after the first CD45RA-depleted DLI
Chronic Graft-versus-Host Disease
This outcome will measure the percentage of participants who develop chronic graft-versus-host disease after CD45RA-depleted DLI. Chronic GVHD will be assessed and graded according to NIH 2014 criteria, including mild, moderate, and severe chronic GVHD.
Measured: Up to 1 years after CD45RA-depleted DLI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 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 1/2
- Primary purpose
- Treatment
- 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
- NCT07662369
- Sponsor's protocol ID
- RJ-BMT-Infection 1.0
- Acronym
- CD45RADLITx
- Status last verified
- May 2026
- First submitted
- 16 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share outcome data via request after article publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Transplantation: a Prospective, Multicenter, Single-arm, Pragmatic Clinical Study
- ClinicalTrials.gov ID
- NCT07662369
- Acronym / sponsor ID
- CD45RADLITx / RJ-BMT-Infection 1.0
- Conditions
- Hematologic Malignancy, Haplo-identical HCT
- Keywords
- CD45RA, DLI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Liquan Hospital
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 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 special donor immune cells (called "CD45RA Depleted DLI") can help treat viral infections that have not improved with standard antiviral drugs. These infections occur after a stem cell transplant. The study will also look at the safety of this treatment.
Detailed description
Due to delayed immune reconstitution and long-term use of immunosuppressants after allogeneic hematopoietic stem cell transplantation, patients remain in a state of prolonged immunocompromise and are prone to various infections, which is one of the leading causes of death after transplantation. The overall response rate of various antiviral drugs ranges from 60% to 80%, meaning 20-40% of patients cannot be effectively treated. Moreover, most antiviral agents have significant toxicities that patients often cannot tolerate. Therefore, finding appropriate and effective antiviral therapeutic strategies is urgently needed for transplant recipients.
Previous studies have indicated that adoptive donor lymphocyte infusion (DLI) can help reconstitute immunity; however, the CD45RA-positive naïve T cells contained in DLI are a major cause of graft-versus-host disease (GVHD). By ex vivo selection to deplete naïve T cells from donor lymphocytes while retaining donor memory T cells (Tm), it may be possible to promote immune reconstitution, clear viral infections, improve the cure rate of viral infections, and reduce the incidence of GVHD. This study is planned as a prospective, multicenter, single-arm, pragmatic clinical trial. We intend to use the CliniMACS® cell selection system to selectively deplete CD45RA-positive T cells ex vivo and infuse the selected donor lymphocytes (DLI) to treat viral infections that are refractory to first-line therapy after hematopoietic stem cell transplantation. We will evaluate the efficacy and safety of this treatment for post-transplant viral infections, as well as its impact on immune reconstitution after transplantation.
Study Objectives:
Primary objective: To evaluate the efficacy and safety of CD45RA Depleted DLI for the treatment of refractory/persistent viral infections after transplantation.
Secondary objective: To evaluate the effect of CD45RA Depleted DLI on the reconstitution of virus-specific T cell (VST) immunity after transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Biological: CD45RA depleted donor lymphocyte infusion (DLI)CD45RA Depleted DLI |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who have undergone hematopoietic stem cell transplantation.
- Presence of viremia and/or viral infection-related disease caused by a single virus or multiple viruses among the following: CMV, EBV, ADV, BK, B19, JC, HHV-6B, HSV1, or HSV2.
- Patients who, after ≥2 weeks of first-line therapy, have persistent viral positivity, no relief or worsening of clinical symptoms, or re-infection with the same pathogen after viral clearance.
- Availability of a suitable lymphocyte donor.
- Adequate organ function, meeting the following laboratory criteria:
Key exclusion criteria (7 listed)
- Active grade II-IV acute graft-versus-host disease (aGVHD).
- Prednisone or equivalent corticosteroid dose > 0.5 mg/kg/day.
- Receipt of anti-thymocyte globulin (ATG), alemtuzumab (Campath), or other T-cell immunosuppressive monoclonal antibodies within 28 days before enrollment.
- Less than 28 days after allogeneic transplantation, or receipt of donor lymphocyte infusion (DLI) or virus-specific T cell (VST) therapy within 28 days before enrollment.
- Uncontrolled or relapsed malignancy.
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) admission with escalated dose | Biological | Treatment Group |
Primary outcome
Percentage of Participants Achieving Overall Response of Viral Infection Based on Quantitative PCR and Clinical Response Criteria
Time frame: 90 days after the first CD45RA-depleted donor lymphocyte infusion
Overall response rate is defined as the percentage of participants who achieve complete response or partial response after CD45RA-depleted DLI. Complete response is defined as negative viral PCR together with disappearance of all virus-related clinical signs and symptoms. Partial response is defined as at least a 50% reduction in viral load from baseline together with at least 1-grade improvement in clinical symptoms. Overall response rate will be calculated as the number of participants with complete response or partial response divided by the total number of evaluable participants.
3 secondary outcomes
Virus-specific T-cell Response
Time frame: 90 days after the first CD45RA-depleted DLI
Grade III-IV Acute Graft-versus-Host Disease
Time frame: 90 days after the first CD45RA-depleted DLI
Chronic Graft-versus-Host Disease
Time frame: Up to 1 years after CD45RA-depleted DLI
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 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Will share outcome data via request after article publication.
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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 1/2 study testing CD45RA depleted donor lymphocyte infusion (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 11 inclusion and 7 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 23 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 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 Xiaoxia Hu, MD, PhD (008613795437259, hu_xiaoxia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Overall Response of Viral Infection Based on Quantitative PCR and Clinical Response Criteria (time frame: 90 days after the first CD45RA-depleted donor lymphocyte infusion). 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 23 Jun 2026.