A 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

Phase 1

• 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.; MedDRA version: 21.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2019-001730-34-GB
• Lead Sponsor: Sangamo Therapeutics France SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-17
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

The following inclusion criteria must be met for all transplant recipients (i.e., recipients to be administered TX200-TR101 and control recipients):
Inclusion Criteria (All Transplant Recipients)
1. 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.
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. Women who are of childbearing potential must have a negative serum pregnancy test at screening and before transplantation.
6. 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.

Additional Inclusion Criteria (Transplant Recipients to be Administered TX200-TR101 Only)
The following additional criteria must be met for transplant recipients to be administered TX200- TR101:
1. HLA-A*02 negative typing (the kidney graft needs to be HLA A*02 positive).
2. HLA-A*69 negative typing.
3. Adequate venous access for leukapheresis, and no other contraindications for leukapheresis.

Additional Inclusion Criteria (Transplant Donors for Transplant Recipients to be Administered TX200- TR101 Only)
The following additional inclusion criterion must be met for transplant donors for transplant recipients to be administered TX200-TR101:
1. HLA-A*02 positive typing.

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 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Exclusion Criteria (All Transplant Recipients)
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) >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