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

NCT05987527 | Active Not Recruiting

• 2 other identifiers: TX200-KT032022-002440-40
• Study Type: observational
• Target: 11
• Locations: 3 countries
• Sites: 5

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.

Conditions

Kidney Transplant Rejection; End Stage Renal Disease

Keywords

Regulatory T-Cells; Genetically modified cells; Chimeric antigen receptor; Long term follow up; T-Regs; Cell Therapy

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival

  Long term safety and tolerability of TX200-TR101 infusion evaluated by overall survival

  Up to 15 years post infusion

• Safety and Tolerability TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.

  Long term safety and tolerability of TX200-TR101 infusion evaluated by and incidence of serious adverse events (SAEs) according to CTCAE V5.0.

  Up to 15 years post infusion

Secondary Outcomes (8)

• Long term graft related outcomes

  Up to 15 years post infusion

• Number of in-patient days in hospital to evaluate the effect of TX200-TR101 over a long term

  Up to 15 years post infusion

• Incidence of Adverse Events related to TX200-TR101 over a long term period

  Up to 15 years post infusion

• Incidence of Adverse Events of special interest as defined in the protocol over long term

  Up to 15 years post infusion

• Change in immunosuppression regime to evaluate long term safety of TX200-TR101

  Up to 15 years post infusion

Study Arms (2)

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: Blood sample

Control group

Subjects underwent a kidney transplant as per planned standard of care in study TX200-KT02 with no study drug administered

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Routine procedures

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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,

You may qualify if:

• Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Sangamo Therapeutics: lead

Study Sites (5)

University Hospitals Leuven

Leuven, Belgium

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Leiden University Medical Centre

Leiden, Netherlands

Location

Erasmus MC, University Medical Center

Rotterdam, Netherlands

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Related Links

• Link to parent study STEADFAST, TX200-KT02

Biospecimen

Retention: NONE RETAINED

Whole blood

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: August 14, 2023
• Study Start: August 15, 2023
• Primary Completion (Estimated): June 11, 2039
• Study Completion (Estimated): June 11, 2039
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); NL (3); GB (1)