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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

Tracking Information
First Submitted Date June 30, 2023
First Posted Date August 14, 2023
Last Update Posted Date April 5, 2024
Actual Study Start Date August 15, 2023
Estimated Primary Completion Date September 4, 2039   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 14, 2023)
  • 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
  • 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.
Original Primary Outcome Measures
 (submitted: August 3, 2023)
  • Safety and Tolerability [ Time Frame: Up to 15 years post infusion ]
    Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival
  • Safety and Tolerability [ 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.
Change History
Current Secondary Outcome Measures
 (submitted: October 2, 2023)
  • Long term graft related outcomes [ Time Frame: Up to 15 years post infusion ]
    Incidence of graft rejection according to the Banff classification criteria
  • 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
  • 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
  • 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
  • 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
  • Change in immunosuppression regime to evaluate long term safety of TX200-TR101 [ Time Frame: Up to 15 years post infusion ]
    Change in immunosuppression regime
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: August 3, 2023)
  • Long term graft related outcomes [ Time Frame: Up to 15 years post infusion ]
    Incidence of graft rejection according to the Banff classification criteria
  • Long term safety [ Time Frame: Up to 15 years post infusion ]
    Number of in-patient days in hospital
  • Long term safety [ Time Frame: Up to 15 years post infusion ]
    Incidence of Adverse Events related to TX20-TR101
  • Long term safety [ Time Frame: Up to 15 years post infusion ]
    incidence of Adverse Events of special interest as defined in the protocol
  • Long term safety [ Time Frame: Up to 15 years post infusion ]
    Incidence of anti-drug antibodies against HLA A2 CAR Tregs
  • Long term safety [ Time Frame: Up to 15 years post infusion ]
    Change in immunosuppression regime
  • Composite efficacy profile of TX200-TR101 [ Time Frame: Up to 15 years post infusion ]
    Incidence of graft loss due to rejection
  • Composite efficacy profile of TX200-TR101 [ Time Frame: Up to 15 years post infusion ]
    Death
  • 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
  • Impact on Quality of Life [ Time Frame: Up to 15 years post infusion ]
    SF-36 Questionnaire scaled with lower score meaning more disability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
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
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.
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, and serum
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,
Condition
  • Kidney Transplant Rejection
  • End Stage Renal Disease
Intervention
  • Diagnostic Test: Urine sample
    Routine procedures
  • Diagnostic Test: Blood sample
    Routine procedures
  • Other: Lifestyle questionnaire
    Lifestyle questionnaire
Study Groups/Cohorts
  • 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

    Interventions:
    • Diagnostic Test: Urine sample
    • Diagnostic Test: Blood sample
    • Other: 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
    Interventions:
    • Diagnostic Test: Urine sample
    • Diagnostic Test: Blood sample
    • Other: Lifestyle questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: August 3, 2023)		 21
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 4, 2039
Estimated Primary Completion Date September 4, 2039   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium,   Netherlands,   United Kingdom
Removed Location Countries Germany
 
Administrative Information
NCT Number NCT05987527
Other Study ID Numbers TX200-KT03
2022-002440-40 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Sangamo Therapeutics
Original Responsible Party Same as current
Current Study Sponsor Sangamo Therapeutics
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Sangamo Therapeutics
Verification Date April 2024