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 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT03664635
Eligibility Criteria:
Inclusion Criteria:
* Refractory/relapsed CD20+ B-NHL (including malignant transformation like Richter's transformation) with no curative treatment option.
* At least 18 years of age
* Estimated life expectancy of more than 3 months
* ECOG performance status (Eastern cooperative oncology group) of 0-2
* Negative serological HBV (Hepatitis B virus) test, negative testing of HCVAb (Hepatitis C virus Antibody), negative HIV1/2 (Human immunodeficiency virus 1/2 ) test within 6 weeks prior to enrollment
* No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential.
* Signed and dated informed consent before conduct of any trial-specific procedure
Exclusion Criteria:
* Participation in another interventional trial that could interact with this trial
* Any evidence 0f CNS (Central nervous system) involvement
* Known history or presence of clinically relevant CNS pathology
* Patients with history of primary immunodeficiency,
* Patients with any history of auto-immune induced condition such as those caused by checkpoint inhibitors, MEK inhibitors or BRAF inhibitors, for example pituitary hypophysitis must be excluded
* Patients with Chronic Lymphocytic Leukemia unless suffering from malignant transformation
* Active systemic fungal, viral or bacterial infection
* Serious cardiac functional incapacity (class III or IV as defined by the New York Heart Association Classification)
* Severe pulmonary disease (DLCO (Transfer factor of the lung for carbon monoxide) and/or FEV1 (Forced expiratory volume in 1 second) \< 65%, dyspnea at rest)
* Liver dysfunction as indicated by a total bilirubin, AST (Aspartate Aminotransferase), and ALT (Alanine aminotransferase) ≥ 2 the institutional ULN (Upper limit of normal) value, unless directly attributable to the patient's tumor
* Creatinine clearance \<50 ml/min calculated according to the modified formula of Cockcroft and Gault
* Pregnant or lactating women
* Active secondary malignancy requiring treatment (except basal cell carcinoma or malignant tumor curatively treated by surgery) within the last 5 years before enrollment.
* Medical condition requiring prolonged use of systemic corticosteroids (\> 1 month)
* Prior therapy with genetically modified substances
* Use of anti-CD20 antibodies within 4 weeks before leukapheresis
* Chemotherapy within 4 weeks prior to leukapheresis
* Other treatment within 4 weeks or two half-lives, whichever is longer before MB-CART20.1 infusion. This pertains to immunomodulatory therapies such as checkpoint inhibitors because of the influence on the immune system
* Concurrent systemic radiotherapy
* Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation e.g. as part of the mandatory lymphodepletion protocol, pre-medication for infusion, rescue medication/salvage therapies for treatment of related toxicities
* Patients in which such medication is contraindicated for other reasons than hypersensitivity (e.g. live vaccines and fludarabine)
* Patients in which trial related procedures are contraindicated as judged by the investigator, e.g. lumbar punctures for CSF (Cerebrospinal fluid) sampling
* Patient's lack of accountability, inability to appreciate the nature, meaning and consequence of the trial and to formulate his/her own wishes correspondingly
* Patients who have a relationship of dependence or employer employee relationship to the sponsor or the investigator
* Committal to an institution on judicial or official order
* Cerebral dysfunction, legal incapacity
* Other investigational treatment within 4 weeks before IMP (Investigational Medicinal Product) infusion
* Clinically relevant autoimmune diseases or history of autoimmune disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03664635
Study Brief:
Protocol Section:
NCT03664635