CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Haploidentical Transplantation

NCT07662369 | Recruiting Phase 1 DMC

• 1 other identifier: RJ-BMT-Infection 1.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. The study will also look at the safety of this treatment.

Conditions

Hematologic Malignancy; Haplo-identical HCT

Keywords

CD45RA; DLI

Outcome Measures

Primary Outcomes (1)

• 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.

  90 days after the first CD45RA-depleted donor lymphocyte infusion

Secondary Outcomes (3)

• Virus-specific T-cell Response

  90 days after the first CD45RA-depleted DLI

• Grade III-IV Acute Graft-versus-Host Disease

  90 days after the first CD45RA-depleted DLI

• Chronic Graft-versus-Host Disease

  Up to 1 years after CD45RA-depleted DLI

Study Arms (1)

Treatment Group

EXPERIMENTAL

CD45RA Depleted DLI

Biological: CD45RA depleted donor lymphocyte infusion (DLI)

Interventions

CD45RA depleted donor lymphocyte infusion (DLI) BIOLOGICAL

CD45RA depleted donor lymphocyte infusion (DLI) admission with escalated dose

Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Liquan Hospital: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, SH, 200025, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Xiaoxia Hu, MD, PhD

CONTACT

008613795437259; hu_xiaoxia@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: June 23, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)