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 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT04691232
Eligibility Criteria:
Inclusion Criteria:
* Patients must have an established diagnosis of UC, with minimum time from diagnosis of ≥3 months
* Patients must be either in remission under the allowed concomitant therapy or must have received all the beneficial pharmacological treatment lines before enrollment and have moderate to severe disease activity (disease should extend 15 cm or more above the anal verge) determined by a modified Mayo score (excluding the friability at grade 1 for the endoscopic sub score) of 6 to 12 with an endoscopic subscore ≥ 2 and no other individual subscore \< 1.
* Patients must have a WHO performance status of 0, 1 or 2 and must be in stable medical condition.
* Patients must be between 18 and 75 years old and must be able and willing to give informed consent.
* Women of child-bearing age must have a negative pregnancy test at enrollment in the study, must be willing to undergo monthly pregnancy tests until at least 3 months after adoptive Treg transfer and must oblige to use effective contraception until at least 3 months after adoptive Treg transfer. A highly effective method of birth control is defined as one that results in a low failure rate (ie, less than 1 percent per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
* Male study patients, who are partners of women of child-bearing age must be willing to use effective contraception until at least 3 months after adoptive Treg transfer. A highly effective method of birth control is defined as one that results in a low failure rate (ie, less than 1 percent per year) when used consistently and correctly, such as sexual abstinence, or a vasectomy. The solely use of condoms is not considered as an effective method of birth control. Therefore, partners of child-bearing age from male study patients should be willing to use implants, injectables, combined oral contraceptives or intrauterine devices (IUDs) a highly effective method of birth control. Information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.
* Patients must be willing to undergo a leukapheresis.
* Patients must be willing to get hospitalized for at least 24 hours following adoptive Treg transfer, and to cooperate for the whole period of the trial.
* Accomplishment of a washout phase for biological therapy of at least 8 weeks or no detectable serum trough levels prior to screening in case of a washout phase less than 8 weeks.
* Concomitant therapy with oral corticosteroids (prednisone or equivalent up to 20 mg/day, stable for 2 weeks at inclusion), budesonide (9 mg/day, stable for 8 weeks at inclusion), 5-ASA (stable for 2 weeks at inclusion) and azathioprine (stable for 8 weeks, initiated at least 3 months ago) is permitted. Concomitant oral corticosteroids can be reduced at the investigator's discretion from visit 5 onwards (e.g. 5 mg reduction per week).≤
Exclusion Criteria:
* Any of the above mentioned inclusion criteria are not met.
* Impaired hematological function (on repeated testing) as indicated by Leukocyte Count ≤ 2,500 /mm3, or Neutrophils ≤ 1,000 / mm3, or Lymphocytes ≤ 700 / mm3, or Platelets ≤ 75,000 / mm3, or Hemoglobin ≤ 9 g / dl22
* Impaired hepatic or renal function as indicated by Serum creatinine ≥ 2.5 mg/100 ml, or Serum Bilirubin ≥ 2.0 mg/100 ml
* Any other major serious illness \[e.g. active systemic infections, immunodeficiency disease, clinically significant heart disease, respiratory disease, bleeding disorders, etc.\] or a contraindication to leukapheresis.
* Evidence for HIV-1, HIV -2, HTLV-1, TPHA, HBV, or HCV infection.
* Patients who have spent a cumulative period of 1 year or more in the UK between the beginning of 1980 and the end of 1996
* Patients who have a family history, which places them at risk of developing Creutzfeldt-Jacob disease
* Patients who have received a corneal or dura mater graft, or who have been treated in the past with medicines made from human pituitary glands
* Other active autoimmune diseases (such as but not limited to Lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis).
* Previous splenectomy or radiation therapy to the spleen.
* Patients with organ allografts.
* Patients with celiac disease.
* Concomitant treatment with chemotherapy, immunotherapy, any investigational drug and paramedical substances.
* Existence or prior history of a malignant neoplasm.
* Organic brain syndrome or significant psychiatric abnormality which would preclude participation in the full protocol and follow up.
* Positive pregnancy test / Pregnancy or lactation. If pregnancy occurs during the course of the trial to female patients, the patient has to be excluded (not valid for partners of male patients treated).
* Known hypersensitivities to human serum albumin and/or DMSO
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
18 Years
Study:
NCT04691232
Study Brief:
Protocol Section:
NCT04691232