Long-Term Follow-Up of Patients who have received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in a prior clinical study.

Long-Term Follow-Up of Patients who have received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in a prior clinical study. - Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56013

Enrollment

Registered

2022-12-29

Start date

2023-06-01

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allograft rejection Renal transplant rejection

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion 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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study. 2.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

Exclusion criteria: 1. Subjects/persons committed to an institution following an administrative or judicial order.

Design outcomes

Primary

Measure	Time frame
From the day of TX200-TR101 infusion through to 15 years post-TX200-TR101 infusion/baseline: • Overall survival • Incidence and grade of Serious Adverse Events (SAEs).	—

Secondary

Measure	Time frame
Secondary From the day of TX200-TR101 infusion through to 15 years post-TX200-TR101 infusion/baseline: • Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing) • Incidence of graft loss due to rejection • Incidence and severity of chronic graft dysfunction, as measured by eGFR • Incidence and (semi-quantitative) intensity of de novo donor-specific anti-HLA antibodies (DSA). Exploratory From the day of TX200-TR101 infusion through to 15 years post-TX200-TR101 infusion/baseline: • Number of in-patient days in hospital • Incidence of any Adverse Events (AE) considered related to TX200-TR101 according to the investigator • Incidence of Adverse Events of Special Interest (AESI), including (irrespective of grade): o Any infection requiring medical intervention; any infection that is suspected or confirmed opportunistic in nature; new-onset diabetes mellitus (NODM), new incidence or exacerbation of a pre-existing neurological disorder; new incidence or exacerbation of a prior rheumatological or other autoimmune disorder; new incidence of a haematological disorder; new incidence or exacerbation of hypertension, new malignancy, or new (up-to 8 years post-infusion) dyslipidaemia requiring medical intervention • Change in immunosuppression regimen to include: o Target levels in blood for each immunosuppressant. o Number and name of drugs given to achieve intended level of immunosuppression. o Any incidence of rescue medication given to avoid potential imminent rejection episode. • Incidence of anti-drug antibodies against HLA-A2 CAR-Tregs. • From the day of TX200-TR101 infusion/baseline through to 15 years post-TX200-TR101 infusion/baseline, any of the following: o Death, or; o Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing), or; o Incidence of graft loss due to rejection, or;	—

Measure

Time frame

Secondary From the day of TX200-TR101 infusion through to 15 years post-TX200-TR101 infusion/baseline: • Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing) • Incidence of graft loss due to rejection • Incidence and severity of chronic graft dysfunction, as measured by eGFR • Incidence and (semi-quantitative) intensity of de novo donor-specific anti-HLA antibodies (DSA). Exploratory From the day of TX200-TR101 infusion through to 15 years post-TX200-TR101 infusion/baseline: • Number of in-patient days in hospital • Incidence of any Adverse Events (AE) considered related to TX200-TR101 according to the investigator • Incidence of Adverse Events of Special Interest (AESI), including (irrespective of grade): o Any infection requiring medical intervention; any infection that is suspected or confirmed opportunistic in nature; new-onset diabetes mellitus (NODM), new incidence or exacerbation of a pre-existing neurological disorder; new incidence or exacerbation of a prior rheumatological or other autoimmune disorder; new incidence of a haematological disorder; new incidence or exacerbation of hypertension, new malignancy, or new (up-to 8 years post-infusion) dyslipidaemia requiring medical intervention • Change in immunosuppression regimen to include: o Target levels in blood for each immunosuppressant. o Number and name of drugs given to achieve intended level of immunosuppression. o Any incidence of rescue medication given to avoid potential imminent rejection episode. • Incidence of anti-drug antibodies against HLA-A2 CAR-Tregs. • From the day of TX200-TR101 infusion/baseline through to 15 years post-TX200-TR101 infusion/baseline, any of the following: o Death, or; o Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing), or; o Incidence of graft loss due to rejection, or;

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Countries

Netherlands

Outcome results