WHO ICTRP trial

MB-CART19.1 in refractory SLE

EUCTR2022-003137-19-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2022-003137-19-DE
Public title MB-CART19.1 in refractory SLE
Scientific title An open-label phase I/IIa, multicenter, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE - MB-CART19.1 in refractory SLE
Primary sponsor Miltenyi Biomedicine GmbH
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Germany
Conditions Adult patients with refractory active systemic lupus erythematosus (SLE) with organ involvement MedDRA version: 21.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal…
Interventions Product Name: MB-CART19.1 Product Code: MB-CART19.1 Pharmaceutical Form: Dispersion for infusion INN or Proposed INN: not available Current Sponsor code: MB-CART19.1 Other descriptive name: T cells transduced with chimeric antigen receptor…
Registration date Dec 23, 2022
Target size 30
Secondary IDs M-2022-398
Registry page clinicaltrialsregister.eu

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