| 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 