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)

Phase 1

• Conditions: Prophylaxis against renal transplant rejection; MedDRA version: 21.1Level: LLTClassification code: 10050436Term: Prophylaxis against renal transplant rejection Class: 10042613; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2024-512579-11-00
• Lead Sponsor: Sangamo Therapeutics France

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-23
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified