RECRUITING

Tolerance Through Mixed Chimerism (Sip-Tego)

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Conditions

Kidney FailureTransplant Recipient (Kidney)Transplant ToleranceImmunosuppresionImmunosuppression After Kidney TransplantationToleranceTransplant without immunosuppressionkidney transplant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, single-institution study to assess the safety and the efficacy of the Sip-Tego regimen for the induction of donor-specific immunologic unresponsiveness to a renal allograft. The investigators propose to treat 6 adult subjects in end-stage renal disease (ESRD) who do not demonstrate evidence of prior sensitization.

Official Title

Tolerance Through Mixed Chimerism (Sip-Tego)

Quick Facts

Study Start:2025-05-31
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06972069

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female 18-65 years of age.
  2. 2. Subjects with chronic kidney disease stage V (GFR\<15ml/min/1.73m2) or ESRD who are treated or imminently be treated with either hemodialysis or peritoneal dialysis.
  3. 3. Candidate for a living-donor renal allograft from an HLA matched or mismatched donor
  4. 4. First or second renal transplant.
  5. 5. EBV Seropositive
  6. 6. Use of FDA-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation
  7. 7. Ability to understand and provide informed consent.
  8. 8. Negative COVID-19 test during screening and two days prior to procedure
  1. 1. ABO blood group-incompatible renal allograft
  2. 2. Participant with a donor-specific antibody (DSA) within 6 months prior to transplant
  3. 3. Persistent Leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (\<100,000/mm3)
  4. 4. Seropositivity for HIV-1, hepatitis B core antigen, or hepatitis C virus (confirmed by hepatitis C virus RNA); or positivity for hepatitis B surface antigen.
  5. 5. Untreated Infection
  6. 6. Left ventricular ejection fraction \< 40% as determined by TTE or clinical evidence of heart failure.
  7. 7. Forced expiratory volume FEV1 or DLCO \< 50% of predicted.
  8. 8. Lactation or pregnancy.
  9. 9. Patients with active cancer or those with a high risk of recurrence following the American Transplant Society
  10. 10. Underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as non-genetic primary focal segmental glomerulosclerosis dense deposit disease, C3 glomerulonephritis, and, atypical hemolytic uremic syndrome).
  11. 11. Prior dose-limiting radiation therapy for treatment of malignant disease.
  12. 12. Known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen. This includes long term cigarette smoking or a family history of malignancy.
  13. 13. Enrollment in other investigational drug studies within 30 days prior to enrollment.
  14. 14. Abnormal (\>2 times lab normal) values for (a) liver function chemistries (ALT, AST, AP), (b) bilirubin, (c) coagulation studies (PT, PTT) , or any patients on chronic anticoagulation therapy.
  15. 15. Allergy or sensitivity to any component of Cyclophosphamide, tacrolimus, Siplizumab, Tegoprubart, or rituximab.
  16. 16. The presence of any medical condition that the investigator deems incompatible with participation in the trial. This includes a history of alcohol abuse or illicit drug use/dependence.
  17. 17. Any chronic or intermittent administration of immunosuppressant medication (such as for inflammatory bowel disease or asthma)
  18. 18. Subjects who have non-insulin dependent diabetes (NIDDM) without good blood glucose control (HbA1c\<8%). Subjects with severe diabetes-related complications, such as advanced retinopathy, gastroparesis, or severe neuropathy that significantly impair their ability to perform normal, independent daily activities, will also be excluded.

Contacts and Locations

Study Contact

Kerry Augusta, RN
CONTACT
617-724-8570
kaugusta@mgb.org

Principal Investigator

Tatsuo Kawai, MD PhD
PRINCIPAL_INVESTIGATOR
Principal Investigator / Transplant Surgeon

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Tatsuo Kawai, MD, PhD

  • Tatsuo Kawai, MD PhD, PRINCIPAL_INVESTIGATOR, Principal Investigator / Transplant Surgeon

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-31
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2025-05-31
Study Completion Date2030-12-31

Terms related to this study

Keywords Provided by Researchers

  • Tolerance
  • Transplant without immunosuppression
  • kidney transplant

Additional Relevant MeSH Terms

  • Kidney Failure
  • Transplant Recipient (Kidney)
  • Transplant Tolerance
  • Immunosuppresion
  • Immunosuppression After Kidney Transplantation