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CD45RA-depleted DLI for the Treatment of Refractory/Persistent Viral Infections After Haploidentical Transplantation (CD45RADLITx)

22. juni 2026 oppdatert av: Ruijin Hospital

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

30

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • SH
      • Shanghai, SH, Kina, 200025
        • Rekruttering
        • Ruijin Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment Group
CD45RA Depleted DLI
Biologisk: CD45RA depleted donor lymphocyte infusion (DLI)
CD45RA depleted donor lymphocyte infusion (DLI) admission with escalated dose

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Achieving Overall Response of Viral Infection Based on Quantitative PCR and Clinical Response Criteria
Tidsramme: 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.
90 days after the first CD45RA-depleted donor lymphocyte infusion

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Virus-specific T-cell Response
Tidsramme: 90 days after the first CD45RA-depleted DLI
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.
90 days after the first CD45RA-depleted DLI
Grade III-IV Acute Graft-versus-Host Disease
Tidsramme: 90 days after the first CD45RA-depleted DLI
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.
90 days after the first CD45RA-depleted DLI
Chronic Graft-versus-Host Disease
Tidsramme: Up to 1 years after CD45RA-depleted DLI
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.
Up to 1 years after CD45RA-depleted DLI

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Ruijin Hospital

Samarbeidspartnere

Shanghai Liquan Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2028

Datoer for studieregistrering

Først innsendt

16. juni 2026

Først innsendt som oppfylte QC-kriteriene

22. juni 2026

Først lagt ut (Faktiske)

23. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • RJ-BMT-Infection 1.0

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Will share outcome data via request after article publication.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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