A single-arm, multi-centre, Phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with primary sclerosing cholangitis, rheumatoid arthritis, lupus nephritis and Crohn’s disease

niversity of Birmingham0 sites60 target enrollmentApril 1, 2022

Overview

Phase: 未知
Intervention: Not specified
Conditions: Primary sclerosing cholangitis, rheumatoid arthritis, lupus nephritis, Crohn’s disease
Sponsor: niversity of Birmingham
Enrollment: 60
Status: Active, not recruiting
Last Updated: last year

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36691123/ (added 24/01/2023) 2023 Other publications in https://doi.org/10.1186/s41687-023-00634-3 Development and usability testing of an electronic patient-reported outcome (ePRO) solution (added 10/10/2023)

Registry

who.int

Start Date

April 1, 2022

End Date

May 1, 2027

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•Current participant inclusion criteria as of 02/07/2024:
•Inclusion criteria for ALL patients:
•1\. Age \= 18 years at Visit 1/1a (screening)
•2\. In this clinical trial, for all cohorts, only participants with severe active disease and refractory to the standard of care treatment (and biologic\-refractory for Rheumatoid Arthritis and Crohn’s Disease cohort) can be included (where a standard of care therapy is available\*)
•3\. Active, uncontrolled, or partially controlled inflammatory disease despite receiving standard\-of\-care therapy (where a standard\-of\-care therapy is available\*)
•4\. On an approved therapy if indicated and available, unless the patient is intolerant of, or has refused, the standard of care therapy
•\*For patients with PSC, no ‘standard of care treatment’ or standard definition for ‘uncontrolled/partially controlled disease’ is available. Patients must have severe active disease to be included.
•Inclusion criteria specific to patients with primary sclerosing cholangitis (PSC):
•1\. Diagnosis of PSC at Visit 1a (screening) as evidenced clinically by Radiological AND/OR histological evidence. Individuals with small duct PSC may be included, only if they have concomitant inflammatory bowel disease
•2\. Serum ALP \= 1\.5 x ULN at Visit 1a and 1b (screening)

•Current participant exclusion criteria as of 02/07/2024:
•Exclusion criteria for ALL patients
•1\. Refusal or lacks the capacity to give informed consent to participate in the POLARISE Trial
•2\. Patient who is unable to participate in follow\-up assessment
•3\. Participation actively or within five half\-lives of Investigational Medicinal Product (IMP) and/or Advanced Therapy Investigational Medicinal Product (ATIMP) in another clinical trial
•4\. Known hypersensitivity to the ATIMP
•5\. Evidence of active malignancy (within three years of Visit 1/1a \[screening]), other than non\-melanoma skin cancer and cervical dysplasia in situ
•6\. Major surgical procedure within 30 days of Visit 1/1a (screening)
•7\. Prior organ transplantation (with the exception of a corneal transplant \= three months prior to Visit 1/1a \[screening])
•8\. Active harmful alcohol consumption as evaluated and documented by the Investigator (as defined by NICE \[3])