RecruitingPhase 2NCT05735717

MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies

Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults With Hematological Malignancies


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

70 participants

Start Date

May 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II, open-label, prospective study of T cell receptor alpha/beta depletion (TCR α/β TCD) peripheral blood stem cell (PBSC) transplantation for children and adults with hematological malignancies. This is a safety/feasibility study of the investigational procedure/product.


Eligibility

Max Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a type of stem cell transplant (using donor cells from blood) with a specific purification method called T-cell receptor alpha/beta depletion. This technique removes certain immune cells that can attack the patient's own body after transplant (called graft-versus-host disease), while preserving cells that fight the cancer. The study is for people with blood cancers (such as leukaemia or MDS) who need a bone marrow transplant from a donor. **You may be eligible if...** - You have been diagnosed with a blood cancer such as AML, ALL, or MDS - Your cancer is at a stage where a stem cell transplant is recommended - You are 60 years old or younger - You are in reasonably good health (Karnofsky or Lansky performance score ≥ 70%) - Your vital organ function is adequate **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an active, uncontrolled infection - You are HIV positive, or have active hepatitis B or C (detectable virus) - You have previously had a bone marrow or stem cell transplant - You have leukaemia that has spread to the brain or spinal cord - You have CML in blast crisis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine

Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.

DRUGBusulfan

Busulfan 82.1 mg\*hr/L IV on days -5 to -2 or days -8 to -5

DRUGMelphalan

Melphalan 50 mg/m2 IV on days -4 to -2

DRUGRituximab

200 mg/m2 intravenous given once on day-1

DRUGLevetiracetam

As seizures have occurred following high dose busulfan, all patients will be treated with Keppra beginning day -6 and continuing until day -1 per institutional guidelines.

BIOLOGICALAlpha/Beta T Cell-Depleted Hematopoietic Stem Cells

Patients will be treated on the most medically appropriate regimen followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

DRUGThymoglobulin

rabbit anti-thymocyte globulin (rATG). Used in conditioning regimens for in vivo depletion of T cells, and the use of fludarabine model-based dosing to optimize dosing.

DRUGCyclophosphamide

Cyclophosphamide 60 mg/kg IV over 2 hours on days -3 and -2


Locations(1)

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

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NCT05735717


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