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Cytokine
Treg Cells + IL-2 for Graft-versus-Host Disease
Phase 1
Waitlist Available
Led By John Koreth, MBBS, DPhil
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recipient of allogeneic hematopoietic stem cell transplantation
Participants must have steroid-refractory cGVHD defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at ≥ 0.25 mg/kg/day for at least 4 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing the safety of the IL-2/Treg cell infusion and finding the best dose to use.
Who is the study for?
This trial is for adults over 18 with chronic GVHD that hasn't improved with steroids. They must have had a stem cell transplant, be in fair health (ECOG 0-2), and not have changed their immunosuppressive meds or received new GVHD therapies recently. Pregnant women, breastfeeding individuals, those on certain drugs, or with active infections or other serious health issues can't join.Check my eligibility
What is being tested?
The study tests the safety and optimal dose of IL-2 plus donor Treg cells to treat cGVHD by calming the immune response after a stem cell transplant. It's an early-phase trial to see if this combination can prevent the body from being 'rejected' by the donor's immune system.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased risk of infection, possible organ inflammation due to altered immune responses, and typical infusion-related symptoms like fever or chills.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received a stem cell transplant from a donor.
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My cGVHD symptoms didn't improve after taking steroids for 4 weeks.
Select...
I am 18 years old or older.
Select...
I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse event profile and the maximum tolerate dose of Treg-enriched infusion plus 8-week low-dose IL-2
Secondary outcome measures
Clinical response of cGVHD as defined by the NIH consensus criteria to Treg-enriched infusion plus 8-week low-dose IL-2
Expansion of Treg cells in the peripheral blood after a Treg-enriched infusion plus 8-week low-dose IL-2
To determine feasibility of Treg-enriched infusion plus 8-week low-dose IL-2
Side effects data
From 2019 Phase 2 trial • 10 Patients • NCT0300723830%
Anemia
20%
Sepsis
20%
Hypertension
20%
Hypophosphatemia
20%
Hyperglycemia
20%
Dyspnea
10%
Bronchial infection
10%
Pneumonitis
10%
Hypotension
10%
Catheter related infection
10%
Hypokalemia
10%
Headache
10%
Anal pain
10%
Anorexia
10%
Oral pain
10%
CD4 lymphocytes decreased
10%
Alanine aminotransferase increased
10%
Lymphocyte count decreased
10%
Nausea
10%
Non-cardiac chest pain
10%
Hypercalcemia
10%
Vascular access complication
10%
Adult respiratory distress syndrome
10%
Atrial flutter
10%
Platelet count decreased
10%
Hyponatremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treg-enriched infusion plus 8-week low-dose Interleukin-2Experimental Treatment2 Interventions
Treg-enriched Cell Dose: Participants will be targeted to a defined dose of donor Treg-enriched total nucleated cells. Initial enrollment will be at target dose-level A. Subsequent cohorts will be dose escalated/de-escalated per the schema. Interleukin-2: Starting the day of Treg-enriched cell infusion, each participant will receive daily subcutaneous IL-2 for self-administration for 8 weeks, followed by a 4-week hiatus. IL-2 will be administered on an outpatient basis. Expected toxicities and potential risks as well as dose modifications are described in Section 6 (Expected Toxicities and Dosing Delays/Dose Modification).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-2
1994
Completed Phase 3
~700
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,847 Total Patients Enrolled
Miltenyi Biomedicine GmbHIndustry Sponsor
33 Previous Clinical Trials
1,598 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,128 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of blood clotting disorders.I have been on a stable dose of steroids for at least 4 weeks.I am 18 years old or older.I have not received low-dose IL-2 therapy in the last 4 weeks.I have not taken T-cell or IL-2 targeted medication in the last 100 days.My cancer has returned after treatment.I have received an organ transplant from another person.I am HIV-positive and on combination antiretroviral therapy.I do not have active, uncontrolled hepatitis B or C.I have received a stem cell transplant from a donor.My cGVHD symptoms didn't improve after taking steroids for 4 weeks.I haven't changed my immunosuppressive medications in the last 4 weeks.My liver, lungs, kidneys, bone marrow, and heart are working well.I am currently taking calcineurin-inhibitor and sirolimus together.I haven't started any new treatments for chronic GVHD in the last 4 weeks.I can take care of myself and perform daily activities.I need more than 1 mg/kg/day of prednisone.I received a donor lymphocyte infusion in the last 100 days.I currently have an infection that isn't under control.You cannot follow the treatment plan for IL-2.
Research Study Groups:
This trial has the following groups:- Group 1: Treg-enriched infusion plus 8-week low-dose Interleukin-2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a pioneering clinical trial?
"To date, 24 active clinical trials for Treg-enriched infusion have been conducted at 45 cities in 10 countries. The inaugural experiment, organised by Key Biologics LLC and comprising of 1230 patients was commenced in 2006 and achieved Phase 2 drug approval status. Subsequently 60 additional studies were launched."
Answered by AI
What is the current count of participants for this research?
"At this juncture, recruitment for this trial has been suspended. Initially posted on November 1st 2013 and last modified on July 5th 2022, patients will have to be patient if they wish to participate in the study. However, there are 175 clinical trials recruiting individuals with organ transplant complications and 24 experiments involving Treg-enriched infusions that require participants."
Answered by AI
Are there any open opportunities for participants to enroll in this clinical trial?
"As of the last update on July 5th 2022, this medical trial is not currently seeking new recruits. Originally posted in November 2013, it may be worth considering one of 175 studies related to complications due to organ transplant stem cells or 24 trials examining the efficacy Treg-enriched infusion therapies."
Answered by AI
Have there been previous experiments involving infusion of Treg-enriched material?
"Presently, 24 Treg-enriched infusion studies are in progress with no Phase 3 trials as yet. While many of these research projects can be found in Meldola, FC there are 70 other places conducting clinical trials related to this treatment method."
Answered by AI
Is there a risk associated with the infusion of Treg-enriched substances for patients?
"Based on the current clinical evidence, our team has judged Treg-enriched infusion's safety to be a 1. This is because it is currently in its first phase of trials and there exists limited data that confirms both efficacy and safety."
Answered by AI
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