Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT05862766
Eligibility Criteria:
Inclusion Criteria:
Cohort A (Desensitization) Inclusion Criteria:
* Age ≥ 18 years
* Listed and will receive a lung transplant or multi-organ transplant involving a lung at NYU Langone Health that is deemed to require peri-transplant desensitization
* Able and willing to provide informed consent
* Pre-transplant DSA \> 5,000 MFI in undiluted serum (measured as individual DSA MFI or as sum of multiple DSAs \>1000 MFI in the undiluted serum)
Cohort B (AMR) Inclusion Criteria:
* Age ≥ 18 years
* Received a lung transplant or multi-organ transplant involving a lung at NYU Langone Health
* Able and willing to provide informed consent
* Allograft dysfunction in the setting of at least one of the following criteria:
* Histopathology suggestive of AMR
* Lung biopsy demonstrating C4d deposition
* Positive DSA \> 2,000 MFI (as individual DSA MFI)
Exclusion Criteria:
* Prior or current treatment with rituximab within 6 months of isatuximab administration
* Prior or current treatment with tocilizumab within 6 months of isatuximab administration
* Contraindication to isatuximab due to intolerance or hypersensitivity
* Pregnant or breastfeeding women
* Known malignancy
* Active infection without adequate treatment or source control
* Known hepatitis B viral infection
* Known HIV infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05862766
Study Brief:
Protocol Section:
NCT05862766