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Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05987527
Recruitment Status : Enrolling by invitation
First Posted : August 14, 2023
Last Update Posted : April 5, 2024
Sponsor:
Information provided by (Responsible Party):
Sangamo Therapeutics

Study Description
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Brief Summary:
This long-term follow-up study is being conducted to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101.

Condition or disease Intervention/treatment
Kidney Transplant Rejection End Stage Renal Disease Diagnostic Test: Urine sample Diagnostic Test: Blood sample Other: Lifestyle questionnaire

Detailed Description:

This is long- term follow up observational trial for patients who participated previously to a multicentre, first-in-human, open-label, single ascending dose, dose-ranging study of autologous, chimeric antigen receptor T regulatory cells (CAR-Treg) in HLA-A2 mismatched living donor kidney transplant recipients, with a control cohort of mismatched kidney transplant recipients of similar immunological risk.

The aim is for this observational long-term follow up study (TX200-KT03) is to collect long-term (up to 15 years post-infusion) safety and tolerability data from subjects enrolled in studies evaluating TX200-TR101. In addition, the long-term effects and durability of the clinical effect of TX200-TR101 in subjects who received TX200-TR101 will be assessed and compared with control participants in the interventional Study (TX200- KT02).

Study Design
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Study Type : Observational
Estimated Enrollment : 21 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Long-Term Follow-Up of Patients Who Have Received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR- Treg Therapy, TX200-TR101) in a Prior Clinical Study
Actual Study Start Date : August 15, 2023
Estimated Primary Completion Date : September 4, 2039
Estimated Study Completion Date : September 4, 2039

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Treatment group

Subjects underwent a kidney transplant as per planned standard of care and were administered study drug TX200-TR101 in study TX200-KT02 post transplantation

Assigned interventions - subjects who received TX200-TR101 in clinical study TX200-KT02

 Diagnostic Test: Urine sample
Routine procedures

Diagnostic Test: Blood sample
Routine procedures

Other: Lifestyle questionnaire
Lifestyle questionnaire
Control group
Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered, up to 6 subjects
 Diagnostic Test: Urine sample
Routine procedures

Diagnostic Test: Blood sample
Routine procedures

Other: Lifestyle questionnaire
Lifestyle questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival [ Time Frame: Up to 15 years post infusion ]
    Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival

  2. Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0. [ Time Frame: Up to 15 years post infusion ]
    Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.


Secondary Outcome Measures :
  1. Long term graft related outcomes [ Time Frame: Up to 15 years post infusion ]
    Incidence of graft rejection according to the Banff classification criteria

  2. Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term [ Time Frame: Up to 15 years post infusion ]
    Number of in-patient days in hospital

  3. Incidence of Adverse Events related to TX200-TR101 over a long term period [ Time Frame: Up to 15 years post infusion ]
    Incidence of Adverse Events related to TX200-TR101

  4. Incidence of Adverse Events of special interest as defined in the protocol over long term [ Time Frame: Up to 15 years post infusion ]
    Incidence of Adverse Events of special interest as defined in the protocol

  5. Incidence of anti-drug antibodies against HLA A2 CAR Tregs to evaluate the effect of TX200-TR101 over a long term [ Time Frame: Up to 15 years post infusion ]
    Incidence of anti-drug antibodies against HLA A2 CAR Tregs

  6. Change in immunosuppression regime to evaluate long term safety of TX200-TR101 [ Time Frame: Up to 15 years post infusion ]
    Change in immunosuppression regime

  7. Incidence of graft loss due to rejection to evaluate the composite efficacy profile of TX200-TR101 [ Time Frame: Up to 15 years post infusion ]
    Incidence of graft loss due to rejection

  8. Incidents of deaths to evaluate composite efficacy profile of TX200-TR101 [ Time Frame: Up to 15 years post infusion ]
    Incidences of death of TX200-TR101 participants

  9. Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate to evaluate the composite efficacy profile of TX200-TR101 [ Time Frame: Up to 15 years post infusion ]
    Incidence of chronic graft dysfunction measured by changes in estimated glomerular filtration rate

  10. Impact on Quality of Life [ Time Frame: Up to 15 years post infusion ]
    SF-36 Questionnaire scaled with lower score meaning more disability scored ranging from 0-100 with 100 representing the highest health related quality of life


Biospecimen Retention:   Samples With DNA
Whole blood, and serum

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Transplant recipients enrolled in the Phase I/IIa study (TX200-KT02) and who have consented to participate in this LTFU study,
Criteria

Inclusion Criteria:

  1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
  2. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.

Exclusion Criteria:

  • N/A
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05987527


Locations
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Belgium
University Hospitals Leuven
Leuven, Belgium
Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Centre
Leiden, Netherlands
Erasmus MC, University Medical Center
Rotterdam, Netherlands
United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom
Sponsors and Collaborators
Sangamo Therapeutics
More Information
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Additional Information:

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Responsible Party: Sangamo Therapeutics
ClinicalTrials.gov Identifier: NCT05987527    
Other Study ID Numbers: TX200-KT03
2022-002440-40 ( EudraCT Number )
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: April 5, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sangamo Therapeutics:
Regulatory T-Cells
Genetically modified cells
Chimeric antigen receptor
 Long term follow up
T-Regs
Cell Therapy
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Male Urogenital Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Chronic Disease
Disease Attributes
Pathologic Processes