MedTrace Logo

TCRαβ-depleted Progenitor Cell Graft With Early Memory T-cell DLI, Plus Selected Use of Blinatumomab, in naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies

NCT07052370 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-31

No results posted yet for this study

Summary

This is a phase I, prospective clinical trial studying the safety and feasibility of providing early memory T-cell DLI.

The primary objective is:

\- To assess the safety and feasibility of early CD45RA-depleted DLI administration.

The secondary objectives are

* To assess the safety and feasibility of the addition of blinatumomab in the early post-transplant period in patients with CD19+ malignancy.
* To measure and describe the pharmacokinetics of rabbit ATG in HCT recipients on this study.

Conditions

  • Hematologic Malignancy

Interventions

DRUG

Thymoglobulin

IV

DRUG

Cyclophosphamide

IV

DRUG

Fludarabine

IV

DRUG

Thiotepa

IV

DRUG

Melphalan

IV

DRUG

Mesna

IV

DRUG

Filgrastim

IV

DRUG

Blinatumomab

IV

DEVICE

CliniMACS

The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.

Sponsors & Collaborators

Principal Investigators

  • Brandon Triplett, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-25
Primary Completion
2028-12-31
Completion
2030-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07052370 on ClinicalTrials.gov