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Cell Therapy

Cellular Therapy for Liver Transplant Recipients (LITTMUS-MGH Trial)

Q: Are there still opportunities to enroll in this clinical investigation?

Affirmative. Clinicaltrials.gov records show that this medical research, which was inaugurated on March 29th 2019, is still recruiting volunteers. Approximately 9 participants are required for the single centre hosting the trial.

Q: What objectives are being sought in this experiment?

The goal of this experiment, set to take place from ≤3 days prior to arTreg-CSB infusion until completion of study participation (Up to 4.5 years), is measuring the Number of Adverse Events (AEs) Attributed to the Investigational Product, arTreg-CSB. Secondary objectives include observing the development rate for de novo Donor Specific Antibodies (DSA), evaluating ≥Grade 3 Infections Following arTreg-CSB Infusion and monitoring any AEs linked with Immunosuppression Withdrawal.

Q: What is the size of the cohort participating in this research project?

Affirmative. According to the clinicaltrials.gov entry, this research study is currently seeking applicants; it was first published on March 29th 2019 and recently updated on November 11th 2021. As of now, 9 patients are needed from one single location.

Q: For which medical conditions is arTreg-CSB routinely prescribed?

arTreg-CSB is widely used to address <a href="https://www.withpower.com/clinical-trials/multiple-sclerosis">multiple sclerosis</a>, but can also be prescribed for <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a>, myelocytic acute rejection; <a href="https://www.withpower.com/clinical-trials/transplant">transplant</a> kidney and Waldenstrom macroglobulinemia.

Q: Does this clinical trial accept participants younger than fifty years of age?

Patients between the ages of 18 to 70 are eligible for this clinical trial. Additionally, there are 306 studies open to those younger than 18 and 749 trials accessible to individuals over 65 years old.

Q: Is there any prior research involving the combination of arTregs and CSB?

Presently, 909 clinical trials research the effectiveness of arTreg-CSB. Of those trials, 170 are in Phase 3 and most take place in Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>; although 31859 sites are running these tests for potential patients.

Q: What are the ideal qualifications for participants of this research project?

This trial seeks nine individuals of legal age (18-70) with end stage liver disease who are undergoing transplantation. Further, these patients must attest to their understanding and acceptance of the informed consent agreement and comply with relevant DAIT guidance regarding vaccinations; agree to contraceptive use if applicable; demonstrate a positive EBV antibody test result; meet clinical donor eligibility criteria for both the patient site as well as manufacturing requirements set forth within seven days prior to blood collection for manufacture purposes, plus be willing to donate biologic samples when requested.

Phase 1 & 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

End-stage liver disease and listed for a living or deceased-donor primary solitary liver transplant

Positive Epstein-Barr virus (EBV) antibody test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-transplant through completion of study participation (up to 4.5 years)

Awards & highlights

LITTMUS-MGH Trial Summary

This trial is exploring whether a cellular therapy can help people with liver transplants stop taking immunosuppressant drugs.

Who is the study for?

This trial is for liver transplant recipients with a positive Epstein-Barr virus test, who've completed treatment for HCV if applicable. Living donors must meet specific eligibility and manufacturing requirements. Contraception use is required, and vaccinations should be up to date. Exclusions include contraindications to certain drugs, chronic conditions that can't pause anticoagulation or immunosuppression, significant heart disease not cleared by a cardiologist, high-risk malignancies, and any factors affecting study compliance.Check my eligibility

What is being tested?

The trial tests cellular therapy aiming to reduce the need for immunosuppression in liver transplant patients using everolimus (a drug), arTreg-CSB (modified T cells), leukapheresis (a procedure to collect white blood cells), cyclophosphamide and mesna (chemotherapy agents). It's an open-label study at MGH where participants are openly given these interventions without randomization.See study design

What are the potential side effects?

Potential side effects may include immune system suppression leading to increased infection risk; reactions related to infusion of modified T cells; kidney issues from everolimus; nausea, bladder irritation from cyclophosphamide; and protective effects against hemorrhagic cystitis from mesna.

LITTMUS-MGH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe liver disease and am on the list for a liver transplant.

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I have tested positive for Epstein-Barr virus antibodies.

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I am considering an organ from a deceased donor.

LITTMUS-MGH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-transplant through completion of study participation (up to 4.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-transplant through completion of study participation (up to 4.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-transplant through completion of study participation (up to 4.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Adverse Events (AEs) Attributed to the Investigational Product's Supportive Regimen (Leukapheresis, Cyclophosphamide and Mesna)

Number of Adverse Events (AEs) Attributed to the Investigational Product, arTreg-CSB

Number of Operationally Tolerant Participants

+2 more

Secondary outcome measures

Duration of Operational Tolerance

Number of AEs Attributed to Immunosuppression Withdrawal

Number of Adverse Events (AEs) Attributed to Cyclophosphamide

+15 more

LITTMUS-MGH Trial Design

1Treatment groups

Experimental Treatment

Group I: arTreg-CSBExperimental Treatment5 Interventions

arTreg CSB: alloantigen-reactive T regulatory cells costimulatory blockade per protocol. The investigational product is donor alloantigen-specific T regulatory cells (arTreg-CSB). Supportive regimen for receipt of arTregs-CSB includes everolimus, leukapheresis, cyclophosphamide, and mesna. Participants will receive a single dose of Treg product (arTreg-CSB). The target dose is 2.5 to 125 x 10^6 total cells. arTreg-CSB will be administered as a single peripheral intravenous (IV) infusion over approximately 15 to 30 minutes. Note: Participants who receive at least the minimum Treg product (arTreg-CSB) dose of 1 to < 2.5 x 10^6 cells will be included in intent-to-treat analysis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

everolimus

2005

Completed Phase 3

~1550

leukapheresis

2004

Completed Phase 3

~230

cyclophosphamide

1994

Completed Phase 3

~8140

mesna

1992

Completed Phase 3

~1420

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,481,123 Total Patients Enrolled

Immune Tolerance Network (ITN)NETWORK

67 Previous Clinical Trials

7,909 Total Patients Enrolled

James F. Markmann, MD, PhDStudy ChairUniversity of Pennsylvania Medical Center: Transplantation

2 Previous Clinical Trials

124 Total Patients Enrolled

Media Library

arTreg-CSB (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03577431 — Phase 1 & 2

Liver Transplant Research Study Groups: arTreg-CSB

Liver Transplant Clinical Trial 2023: arTreg-CSB Highlights & Side Effects. Trial Name: NCT03577431 — Phase 1 & 2

arTreg-CSB (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03577431 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to enroll in this clinical investigation?

"Affirmative. Clinicaltrials.gov records show that this medical research, which was inaugurated on March 29th 2019, is still recruiting volunteers. Approximately 9 participants are required for the single centre hosting the trial."

Answered by AI

What objectives are being sought in this experiment?

"The goal of this experiment, set to take place from ≤3 days prior to arTreg-CSB infusion until completion of study participation (Up to 4.5 years), is measuring the Number of Adverse Events (AEs) Attributed to the Investigational Product, arTreg-CSB. Secondary objectives include observing the development rate for de novo Donor Specific Antibodies (DSA), evaluating ≥Grade 3 Infections Following arTreg-CSB Infusion and monitoring any AEs linked with Immunosuppression Withdrawal."

Answered by AI

What is the size of the cohort participating in this research project?

"Affirmative. According to the clinicaltrials.gov entry, this research study is currently seeking applicants; it was first published on March 29th 2019 and recently updated on November 11th 2021. As of now, 9 patients are needed from one single location."

Answered by AI

For which medical conditions is arTreg-CSB routinely prescribed?

"arTreg-CSB is widely used to address multiple sclerosis, but can also be prescribed for leukemia, myelocytic acute rejection; transplant kidney and Waldenstrom macroglobulinemia."

Answered by AI

Does this clinical trial accept participants younger than fifty years of age?

"Patients between the ages of 18 to 70 are eligible for this clinical trial. Additionally, there are 306 studies open to those younger than 18 and 749 trials accessible to individuals over 65 years old."

Answered by AI

Is there any prior research involving the combination of arTregs and CSB?

"Presently, 909 clinical trials research the effectiveness of arTreg-CSB. Of those trials, 170 are in Phase 3 and most take place in Philadelphia, Pennsylvania; although 31859 sites are running these tests for potential patients."

Answered by AI

What are the ideal qualifications for participants of this research project?

"This trial seeks nine individuals of legal age (18-70) with end stage liver disease who are undergoing transplantation. Further, these patients must attest to their understanding and acceptance of the informed consent agreement and comply with relevant DAIT guidance regarding vaccinations; agree to contraceptive use if applicable; demonstrate a positive EBV antibody test result; meet clinical donor eligibility criteria for both the patient site as well as manufacturing requirements set forth within seven days prior to blood collection for manufacture purposes, plus be willing to donate biologic samples when requested."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Liver Transplantation With Tregs at MGH

2019. "Liver Transplantation With Tregs at MGH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03577431.

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