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A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients (STEADFAST)
EU CTIS ID: 2024-512579-11-00
What this study is testing
To evaluate the short-term safety and tolerability of TX200-TR101 from the day of TX200-TR101 infusion within 28 days post TX200-TR101 infusion.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
- 2. Male or female aged between 18 and 70 (inclusive) years.
- 3. Have diagnosis of ESRD and currently waiting for a new kidney from an identified live donor.
- 4. Subjects who will be single organ recipients (kidney).
- 5. Normal or non-clinically significant abnormality in the electrocardiogram (ECG), at investigator’s discretion.
- 6. Women who are of childbearing potential must have a negative serum pregnancy test at screening and before transplantation.
You likely can't join if
- 1.HLA identical to the prospective organ donor.
- 2.Subjects with prior organ transplant.
- 3.Positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
- 4.Subjects with panel-reactive antibody (PRA) greater than 20% within 6 months prior to enrolment.
- 5. Subjects with current or recent (within 6 months) donor-specific antibodies.
- 6. Subjects with underlying renal disease with a high risk of disease reoccurrence in the transplanted kidney including primary focal segmental glomerulosclerosis, types I or II membranoproliferative glomerulonephritis, C3 glomerulopathy, or haemolytic-uraemic syndrome (HUS), including atypical HUS.
See the full eligibility criteria
- 1. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC) or Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
- 2. Male or female aged between 18 and 70 (inclusive) years.
- 3. Have diagnosis of ESRD and currently waiting for a new kidney from an identified live donor.
- 4. Subjects who will be single organ recipients (kidney).
- 5. Normal or non-clinically significant abnormality in the electrocardiogram (ECG), at investigator’s discretion.
- 6. Women who are of childbearing potential must have a negative serum pregnancy test at screening and before transplantation.
- 7. Able and willing to use a highly effective method of contraception from the signing of the informed consent through the last study visit, for male and female subjects with reproductive potential.
- 1.HLA identical to the prospective organ donor.
- 2.Subjects with prior organ transplant.
- 3.Positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
- 4.Subjects with panel-reactive antibody (PRA) greater than 20% within 6 months prior to enrolment.
- 5. Subjects with current or recent (within 6 months) donor-specific antibodies.
- 6. Subjects with underlying renal disease with a high risk of disease reoccurrence in the transplanted kidney including primary focal segmental glomerulosclerosis, types I or II membranoproliferative glomerulonephritis, C3 glomerulopathy, or haemolytic-uraemic syndrome (HUS), including atypical HUS.
- 7. Concomitant clinically active local or systemic infection.
- 8. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases (i.e., cardiovascular, pulmonary, haematologic, gastrointestinal, hepatic, neurological, malignancy or infectious diseases) or laboratory abnormality (except ESRD) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.