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

Hong Kong Children's Hospital

Status and phase

Enrolling

Phase 2

Conditions

Hematopoietic Organs; Disorder

Treatments

Biological: CD62L depleted donor lymphocyte infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT06034535

HKCH-REC-2022-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

23 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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