Table 1.
Key inclusion and exclusion criteria of transplant recipients and transplant donors in the STEADFAST study
| Inclusion criteria | Exclusion criteria |
|---|---|
| Transplant recipients | |
| Aged between 18 and 70 yrs (inclusive) | HLA identical to the prospective organ donor |
| Diagnosis of ESRD and currently waiting for a new kidney from an identified live donor | Known hypersensitivity or contraindications for IS |
| Single-organ recipients (kidney) | Prior organ transplant |
| Normal or nonclinically significantly abnormal electrocardiogram | Evidence of HIV, syphilis, EBV, HBV, or HCV infection or prespecified hepatic and hematologic laboratory abnormalities |
| HLA-A∗02 negativea | Positive flow-cytometric crossmatch using donor lymphocytes and recipient serum |
| HLA-A∗69 negativea,b | PRA > 20% recent or historic |
| Adequate venous access for leukapheresis, and no other contraindications for leukapheresisa | Current, recent, or historical donor-specific antibodies |
| Previous treatment with any desensitization procedure | |
| Underlying renal disease with a high risk of disease reoccurrence in the transplanted kidney | |
| Concomitant clinically active local or systemic infection | |
| Systemic immunosuppressive agents administered for other indications | |
| Significant unstable or poorly controlled acute or chronic 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, including high risk of renal thrombotic event | |
| Current or previous history of malignancy (within the last 5 yr) | |
| Transplant donors | |
| Age ≥18 yr | Evidence of HBV or HCV infection |
| ABO blood type compatible with the organ recipient | |
| Negative serology result for HIV and syphilis | |
| HLA-A∗02 positivec |
CAR, chimeric antigen receptor; EBV, Epstein-Barr virus; ESRD, end-stage renal disease; HBV, hepatitis B virus; HCV, hepatitis C virus; HLA, human leukocyte antigen; HLA-A∗02/69, human leukocyte antigen class I molecule A∗02/69; IS, immunosuppressive; PRA, panel-reactive antibody; ScFv, single-chain variable fragment.
Inclusion criterion only for transplant recipients in the TX200-TR101 cohort.
Transplant recipients in the TX200-TR101 cohort must be HLA-A∗69 negative because in vitro studies using an HLA-A∗02-CAR constructed from the same humanized ScFv used to manufacture TX200-TR101 showed some cross-reactivity between the HLA-A∗02-CAR and the HLA-A∗69 allele.
Inclusion criterion only for transplant donors for the TX200-TR101 cohort.