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Multiple Donor Treg DLI for Severe Refractory Chronic GVHD

NCT02749084 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-02-02

No results posted yet for this study

Summary

This is a INTERVENTIONAL TRANSPLANTATION STUDY WITHOUT DRUGS.

The INTERVENTION is represented by the INFUSION of DONOR T REGULATORY CELL-ENRICHED LYMPHOCYTES to PATIENTS suffering from REFRACTORY CHRONIC GVHD after ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION.

The study includes a DOSE ESCALATION PHASE followed by a MTD PHASE as detailed in the following chapter.

The primary objective of the dose escalation study will be SAFETY, leading to the definition of the MTD of T reg cells. For the MTD study the primary objective will be the OVERALL RESPONSE RATE at three months after the 3rd Treg infusion.

The study is single center single arm open label and includes a DOSE ESCALATION phase followed by an EXTENDED PHASE with the MAXIMUM TOLERATED DOSE (MTD).

The aim of the study is to assess whether multiple infusions of donor-derived purified T regulatory cells (T reg DLI) in patients with steroid-refractory chronic GVHD is safe and whether it may induce clinical remission of GVHD.

Conditions

Interventions

BIOLOGICAL

T reg DLI

Purified Treg cells will be obtained from the original HSC donor (T reg DLI). Tregs preparation will start with unstimulated donor leukapheresis from the original stem cell donor. The apheresis product will be provided to the Cell Factory "Calori",Milano, where T reg purification will take place. T reg cells will be PURIFIED utilizing the CliniMACS Plus Systems for depletion of CD8 and CD19 positive cells and enrichment for CD25high cells. Release Criteria of Treg cell preparation will be defined. The product will be infused into the recipient through a venous catheter.

Sponsors & Collaborators

Principal Investigators

  • Mario Arpinati · Hematology and Medical Oncology Institute "L. e A. Seràgnoli"

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-03
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases
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 NCT02749084 on ClinicalTrials.gov