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NCT Number: NCT06034535

CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation

In this clinical trial, the investigators aim to apply CD62L depleted donor lymphocyte infusion (DLI) together with in vitro T cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) to treat patients with malignant or non-malignant disease in need of HSCT. The investigators shall evaluate the graft failure-free, graft-versus-host disease (GVHD)-free survival at one year, frequency of adverse events and post-transplant complications, and immunoreconstitution.

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Key information

Conditions

Hematopoietic Organs; Disorder

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

The peripheral stem cell harvest product from the patient's related haploidential donor will be divided into two portions. One portion will undergo T cell receptor (TCR) αβ depletion and the other portion will undergo CD62L depletion. Both depleted products will be infused intravenously to the patient on the same day.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient who requires allogeneic hematopoietic stem cell transplant, has no human leukocyte antigen (HLA)-matched sibling donor but has an HLA-haploidentical donor.
  • Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy
  • Karnofsky or Lansky performance status score ≥50

Exclusion criteria

  • Pregnant or lactating woman
  • HIV infection
  • Patients for whom alternative treatment is deemed more appropriate by treating physician
  • Patients who are unlikely to benefit from haploidentical hematopoietic stem cell transplantation, e.g., terminal malignancy with multiorgan failure

Treatment and study plan

CD62L depleted donor lymphocyte infusion

Biological

Intravenous infusion of CD62L depleted donor lymphocytes

Primary outcomes

  1. Graft failure-free, GVHD-free survival

    Time frame: up to 1 year

    From the date of treatment start until the date of graft failure or GVHD or death from any cause, whichever comes first, assessed up to 1 year

Secondary outcomes

  1. Overall survival

    Time frame: up to 1 year

    From the date of treatment start until the date of death from any cause, assessed up to 1 year

  2. Proportion of patients who develop relapse among those with malignant diseases

    Time frame: up to 1 year

    Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission

  3. Proportion of patients who develop graft failure

    Time frame: up to 1 year

    Graft failure is defined as donor cells <5% in whole blood

  4. Proportion of patients who develop infection

    Time frame: up to 1 year

    Any microbiologically documented infections are included

  5. Proportion of patients who develop acute graft-versus-host disease

    Time frame: up to 1 year

    Acute graft-versus-host disease is defined by MAGIC criteria

  6. Proportion of patients who develop chronic graft-versus-host disease

    Time frame: up to 1 year

    Chronic graft-versus-host disease is defined by NIH criteria

  7. Proportion of patients who develop adverse events not mentioned in outcomes 4-7

    Time frame: up to 1 year

    Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)

  8. Blood T lymphocyte count at 3 months

    Time frame: at 3 months

    Mean T lymphocyte count in blood among evaluable patients

  9. Blood T lymphocyte count at 1 year

    Time frame: at 1 year

    Mean T lymphocyte count in blood among evaluable patients

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Cheuk

CONTACT

[email protected]

85235136049

Sponsors and collaborators

Lead sponsor

Hong Kong Children's Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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