NCT07672964Not yet recruitingPhase 1
CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation
CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Transplantation: a Prospective, Multicenter, Single-arm, Pragmatic Clinical Study
Source: ClinicalTrials.gov · Last updated 29 Jun 2026
Brief summary (registry, in English)
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?
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT07672964
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 1 Jul 2026 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active aGVHD requiring prednisone or equivalent corticosteroid \>0.5 mg/kg/day
Other illness
- Active grade II-IV acute graft-versus-host disease (aGVHD)
- Active viral infection
- Uncontrolled or relapsed malignancy
Lab values
- 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.
Other
- Patients meeting any of the following criteria will be excluded from this study:
Who the study is looking for
- 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
- 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.
Age in the registry: 14 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.