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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
72 Years
Healthy volunteers
No
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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.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
Primary outcome measure(s)
Safety and Tolerability of TX200-TR101 infusion evaluated by overall survival — 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. — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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