CD45RA-depleted DLI for the Prevention of Viral Infections in High-risk Patients After Haploidentical Transplantation

NCT07672964 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: RJ-BMT-Prophylaxis 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 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?

Conditions

Hematologic Malignancy; Haplo-identical HCT

Keywords

CD45RA; DLI

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Up to 3 months after first infusion

• Absolute Counts of Peripheral Blood Lymphocyte Subsets as Measured by Flow Cytometry

  Up to 1 year after the first CD45RA-depleted DLI

• Virus-Specific T-Cell Immune Responses After CD45RA-Depleted DLI

  Up to 3 months after the first CD45RA-depleted DLI, assessed at Days 14, 28, 60, and 90.

Study Arms (1)

Prevention Group

EXPERIMENTAL

Prophylactic CD45RA-depleted DLI

Biological: CD45RA-depleted DLI

Interventions

CD45RA-depleted DLI BIOLOGICAL

CD45RA Depleted DLI by ex vivo CliniMACS® prepared from mononuclear cell leukapheresis

Prevention Group

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

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)
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai Liquan Hospital: collaborator

Study Sites (1)

Ruijin Hospital

Shanghai, SH, 200025, China

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)