Protocol adding anti-CD25 antibody to myeloablative allogeneic stem cell transplant to prevent graft-versus-host disease in children with EBV T/NK lymphoproliferative disease

Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease

This trial will try adding a humanized anti-CD25 antibody to the standard transplant regimen to prevent or reduce acute and chronic graft-versus-host disease in children with EBV-associated T/NK lymphoproliferative disease who are receiving an allogeneic stem cell transplant.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 0 Years to 18 Years
• Sex: All
• Sponsor: Beijing Children's Hospital (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07029958 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional protocol enrolls patients age 18 or younger with EBV-T/NK lymphoproliferative disease undergoing myeloablative allogeneic hematopoietic stem cell transplantation at Beijing Children's Hospital and adds a recombinant humanized anti-CD25 monoclonal antibody to the conditioning regimen. The antibody targets CD25-expressing activated T cells to blunt the alloreactive immune responses that drive acute and chronic graft-versus-host disease. Key outcomes include incidence and severity of acute and chronic GVHD, engraftment success, thrombotic microvascular disease, early EBV reactivation, relapse, and other transplant-related complications. Donor eligibility requires meeting specified age, related/unrelated or mismatch, T-cell dose, or disease-activity criteria, and participants must provide informed consent and complete inpatient transplant care at the center.

Who should consider this trial

Good fit: Children ≤18 years with a confirmed diagnosis of EBV-T/NK LPD by ICC2022 who plan to undergo allogeneic HSCT at Beijing Children's Hospital and meet the specified donor and consent criteria.

Not a fit: Patients with expected survival under three months from multiorgan failure, those not proceeding to allo HSCT at the center, or those who decline or do not meet donor eligibility are unlikely to benefit.

Why it matters

Potential benefit: If successful, adding anti-CD25 could lower rates and severity of acute and chronic GVHD and reduce related complications, improving transplant recovery and long-term outcomes for these children.

How similar studies have performed: Anti-CD25 antibodies such as basiliximab have been used in other transplant settings with mixed results for reducing GVHD, but using this approach specifically for pediatric EBV-T/NK LPD is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Meet the diagnosis of EBV-T/NK lymphoproliferative disease (EBV-T/NK LPD) according to the ICC2022 diagnostic criteria
* Plan to undergo allogeneic hematopoietic stem cell transplantation (allo HSCT) in our hospital
* Age ≤ 18 years old
* Sign informed consent form
* Meet one of the following conditions (haploid donors must meet one of the above conditions, unrelated donors must meet two of the above conditions): ① donor age≥40 years old; ② The donor source is unrelated donor or haplotype related female or collateral donor (brother sisters, etc.) with ≥ 1 point mismatch; ③ CD3≥4 x 10 \^ 8/kg before transplantation; ④ The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; ⑤ ATG (or ATLG (1:2)/ALG (1:20) equivalent dose)\<10mg/kg

Exclusion Criteria:

* The expected survival period for multiple organ failure is no more than 3 months
* Not signing the informed consent form

Where this trial is running

Beijing

• Beijing Children's Hospital Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Jun Yang

Conditions EBV-T/NK LPD