Active — Not RecruitingNot Applicable

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

Belgium, Netherlands, United Kingdom11 participantsStarted 2023-08-15

Plain-language 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.

Who can participate

Age range18 Years – 72 Years

SexALL

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Inclusion criteria

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Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.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

What they're measuring

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

Timeframe: 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.

Timeframe: Up to 15 years post infusion

Trial details

NCT IDNCT05987527

SponsorSangamo Therapeutics

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2039-06-11

View on ClinicalTrials.gov More Kidney Transplant Rejection trials