mb-cart20.1 lymphoma

Conditions: Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; B-cell Lymphoma Refractory; B-cell Lymphoma Recurrent

Summary: this trial is a phase i/ii trial to assess safety, dose finding and feasibility of ex vivo generated mb-cart20.1 cells in patients with relapsed or refractory cd20 positive b-nhl.

mb-cart20.1 consists of autologous anti-cd20 chimeric antigen receptor (car) transduced cd4 /cd8 enriched t cells targeting cd20-positive tumor cells in non-hodgkin-lymphoma (nhl)

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