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Clinical Trials/EUCTR2022-002440-40-DE
EUCTR2022-002440-40-DE
Active, not recruiting
Phase 1

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

Sangamo Therapeutics France SAS0 sites15 target enrollmentDecember 20, 2022
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ConditionsPrevention of immune mediated allograft rejection in patients with end-stage renal disease (ESRD) who are tissue typed as HLA-A*02 negative and have received a kidney transplant from an HLA-A*02 positive living donor.MedDRA version: 21.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Immune system processes [G12]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Prevention of immune mediated allograft rejection in patients with end-stage renal disease (ESRD) who are tissue typed as HLA-A*02 negative and have received a kidney transplant from an HLA-A*02 positive living donor.
Sponsor
Sangamo Therapeutics France SAS
Enrollment
15
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 20, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

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Subjects who enrolled in the Phase I/IIa study TX200\-KT02, received a transplanted kidney and have either completed or withdrawn from that study.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.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 10
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 5

Exclusion Criteria

  • •1\. Subjects/persons committed to an institution following an administrative or judicial order.

Outcomes

Primary Outcomes

Not specified

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ong-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.Allograft rejectionRenal transplant rejection1002766510029149
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ong-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)Kidney Transplant RejectionMedDRA version: 21.1Level: LLTClassification code: 10050436Term: Prophylaxis against renal transplant rejection Class: 10042613Therapeutic area: Phenomena and Processes [G] - Immune system processes [G12]
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