RecruitingPhase 1NCT05088356

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

Phase 1 Trial for Patients With Advanced Hematologic Malignancies Undergoing Reduced Intensity Allogeneic HCT With a T-cell Depleted Graft With Infusion of Conventional T-cells and Regulatory T-cells


Sponsor

Stanford University

Enrollment

77 participants

Start Date

Sep 7, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a type of bone marrow transplant (called allogeneic HCT) that uses a less intense preparation regimen and a specially processed donor graft to reduce side effects, for people with advanced blood cancers like leukemia or myelodysplastic syndrome. **You may be eligible if...** - You have been diagnosed with acute myeloid or lymphoid leukemia, chronic myelogenous leukemia, myelodysplastic syndrome, or a related blood cancer - Your disease is in remission, or in certain cases, has a small amount remaining (minimal residual disease) - A matched or partially matched bone marrow donor is available for you - You are in adequate overall health to undergo a transplant **You may NOT be eligible if...** - You have active uncontrolled infection - Your organ function (heart, liver, lungs, kidneys) is significantly impaired - You have already had a prior allogeneic transplant (depending on study arm) - You are pregnant or breastfeeding 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

DRUGPurified regulatory T-cells (Treg) plus CD34+ HSPC

Purified regulatory T-cells (Treg) plus CD34+ hematopoietic progenitor cells ("CD34+ HSPC"), followed by conventional T-cells (Tcon) Manufactured at SCTT Laboratory, dose 1x10\^6 cells/ kg to 3x10\^6 cells/kg

DRUGFludarabine

Fludarabine (160 mg/m2)

DRUGMelphalan

Melphalan (50 mg/m2)

DEVICECliniMACS CD34 Reagent System

The CliniMACS® CD34 Reagent System is a medical device that is used in vitro to select and enrich specific cell populations is manufactured by Miltenyi Biotec

DRUGTacrolimus

4-6ng/mL

DRUGCyclophosphamide

40mg/kg

DRUGPlerixafor

Dose 0.24 mg/kg, manufactured by Genzyme

DRUGFilgrastim granulocyte colony-stimulating factor (G-CSF) or equivalent

Single-use vials contain either 300 mcg or 480 mcg filgrastim at a fill volume of 1.0 mL or 1.6 mL

DRUGThiotepa

Thiotepa 10 mg/kg

DRUGMycophenolate Mofetil (MMF)

MMF 1000 mg BID

DRUGRuxolitinib

Ruxolitinib 5 mg BID

DRUGSirolimus

5 - 8 ng/mL


Locations(1)

Stanford University

Stanford, California, United States

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NCT05088356


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