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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic Organs; Disorder
• Intervention / Treatment: Biological: CD62L depleted donor lymphocyte infusion

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 23
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Daniel Cheuk; Phone Number: 85235136049; Email: cheukkld@gmail.com

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Hong Kong Children's Hospital
    • Contact: Daniel Cheuk; Phone Number: 852-35136049; Email: cheukkld@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; CD62L depleted donor lymphocyte infusion	Biological: CD62L depleted donor lymphocyte infusion; Intravenous infusion of CD62L depleted donor lymphocytes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft failure-free, GVHD-free survival	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	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	From the date of treatment start until the date of death from any cause, assessed up to 1 year	up to 1 year
Proportion of patients who develop relapse among those with malignant diseases	Relapse is defined as reappearance of biopsy-proven malignant disease after complete remission	up to 1 year
Proportion of patients who develop graft failure	Graft failure is defined as donor cells <5% in whole blood	up to 1 year
Proportion of patients who develop infection	Any microbiologically documented infections are included	up to 1 year
Proportion of patients who develop acute graft-versus-host disease	Acute graft-versus-host disease is defined by MAGIC criteria	up to 1 year
Proportion of patients who develop chronic graft-versus-host disease	Chronic graft-versus-host disease is defined by NIH criteria	up to 1 year
Proportion of patients who develop adverse events not mentioned in outcomes 4-7	Adverse events are graded according to Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 5 (CTCAEv5)	up to 1 year
Blood T lymphocyte count at 3 months	Mean T lymphocyte count in blood among evaluable patients	at 3 months
Blood T lymphocyte count at 1 year	Mean T lymphocyte count in blood among evaluable patients	at 1 year

Collaborators and Investigators

• Sponsor: Hong Kong Children's Hospital
• Investigators: Principal Investigator: Daniel Cheuk, Hong Kong Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HKCH-REC-2022-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No