Deutsches Leukämie-Studienregister
Studie: UC02-123-01 UniCarT

Kurzübersicht
Öffentlicher Titel Phase I Studie zu UniCAR02-T Zellen und TM123 bei CD123 positiven hämatologischen Erkrankungen
Wissenschaftl. Titel Multicenter, Open-label, Adaptive Design Phase I Trial With Genetically Modified T-cells Carrying Universal Chimeric Antigen Receptors (UniCAR02-T) in Combination With CD123 Target Module (TM123) for the Treatment of Patients With Hematologic and Lymphatic Malignancies Positive for CD123
Kurztitel UC02-123-01 UniCarT
Studiennummer KN/ELN LN_NN_2020_703
Studiengruppe NN
Studienphase Phase I
Erkrankung Sonstige Studien (Sonstige) - .
Akute lymphatische Leukämie (ALL) - Reife B-ALL/NHL
Akute myeloische Leukämie (AML) - AML alle außer FAB M3
Leukämiestadium rezidiviert/refraktär
Einschlusskriterien
  • Male or female patients, age >= 18 years
  • Documented definitive diagnosis at screening of AML, B-ALL or BPDCN (according to standard of care testing) and CD123 positivity of more than 20 % of blasts. Relapsed or refractory AML, Relapsed or refractory B-ALL (in patients aged over 25 years or over 18 years without access to an approved chimeric antigen receptor (CAR)-T cell product at time point of potential inclusion into this study), Patients with histological and/or cytological evidence of BPDCN in the peripheral blood, bone marrow (BM), spleen, lymph nodes, skin, and/or other sites that is persistent/recurrent following prior standard of care treatment for BPDCN
  • Eastern Cooperative Oncology Group (ECOG) of 0 to 1
  • Life expectancy of at least 2 months
  • Adequate renal and hepatic laboratory assessments: Adequate cardiac function, i.e. left ventricular ejection fraction (LVEF) of >= 45 % as assessed by transthoracic two-dimensional echocardiography
  • Permanent venous access existing (e.g. port-system) resp. acceptance of implantation of a device
  • Able to give written informed consent
  • Weight >= 45 kg
  • Negative pregnancy; routinely using a highly effective method of birth control
Ausschlusskriterien
  • Acute promyelocytic leukemia (t15;17) and T-ALL
  • Manifestation of AML, ALL or BPDCN in central nervous system
  • Bone marrow failure syndromes
  • Cardiac disease: i.e. heart failure (NYHA III or IV); unstable coronary artery disease, myocardial infarction or serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy within the last 6 months prior to study entry
  • Patients undergoing renal dialysis
  • Pulmonary disease with clinical relevant hypoxia
  • Parkinson, epilepsy and, stroke or presence or history of seizures, paresis, aphasia or intracranial hemorrhage
  • History or presence of disseminated intravascular coagulation (DIC) or thromboembolism
  • Hemolytic anemia
  • Multiple sclerosis
  • Active infectious disease considered by investigator to be incompatible with protocol or being contraindications for lymphodepletion therapy
  • Presence of urotoxicity from previous chemo- or radiotherapy or urinary outflow obstruction
  • Allogeneic stem cell transplantation within last two months or Graft versus host disease (GvHD) requiring immunosuppressive therapy
  • Vaccination with live viruses less than 2 weeks prior lymphodepletion therapy
  • Major surgery within 28 days
  • Other malignancy requiring active therapy but adjuvant endocrine therapy is allowed
  • Treatment with any investigational drug substance or experimental therapy within 4 weeks or 5 half-lives (whatever is shorter) of the substance prior to the day of apheresis
  • Prior treatment with gene therapy products
  • Use of checkpoint inhibitors within 5 half-lives of the respective substance
  • Autoimmune diseases requiring systemic steroids or other systemic immunosuppressants
  • Pregnant or breastfeeding women
  • Psychologic disorders, drug and/or significant active alcohol abuse
  • Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • Presence of autoantibodies against La/Sjögren syndrome (SS)-B or presence or history of autoimmune diseases
  • Known hypersensitivity to cellular component (UniCAR02-T) and/or targeting module (TM123) excipients or to compounds of the lymphodepletion therapy or tocilizumab or corticosteroids
  • Evidence suggesting that the patient is not likely to follow the study protocol
  • Incapability of understanding purpose and possible consequences of the trial
  • Patients who should not be included according to the opinion of the investigator
Alter >= 18 Jahre
Status Aktiv
Beginn der Rekrutierung 23.06.2020
Kurzprotokoll Kurzprotokoll
Sponsoren Cellex Patient Treatment GmbH
Registrierung in anderen Studienregistern ClinicalTrials.gov NCT04230265
European Clinical Trials Database - EUDRACT 2019-001339-30
erstellt 19.11.2020 Zenawit Krüger
geändert 23.12.2020 Student Studienregister
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