Clinical trial
Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia/Lymphoma in Children/Young Adults
Name
CD19CAR-T_LL_children
Description
The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.
Trial arms
Trial start
2020-10-26
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Recruiting
Phase
Early phase I
Treatment
CD19 CAR-T-cells
One dose of CD19 CAR-T cells (1\*10e6 CAR+ T-cells/kg) by intravenous infusion.
Arms:
CD19 CAR-T cells immunotherapy
Tocilizumab
Before 1h of CAR-T cells infusion a patient receive tocilizumab (8 mg/kg).
Arms:
CD19 CAR-T cells immunotherapy
Other names:
Actemra
Size
10
Primary endpoint
Incidence of Treatment-Emergent Adverse Events
1 month
Eligibility criteria
Inclusion Criteria:
* CD19+ relapsed or refractory lymphoblastic leukemia/lymphoma;
* Karnofsky or Lansky performance scale greater or equal to 70;
* T-cells count in peripheral blood \>150 cells/µL;
* Written informed consent.
Exclusion Criteria:
* primary immunodeficiencies or genetic syndromes;
* neurologic diseases;
* autoimmune diseases or polyallergie;
* transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;
* GvHD grade 2-4;
* uncontrolled systemic infection;
* hypoxia (Sp02\<90%)
* severe hepatic dysfunction: ALT or AST \>=3x upper limit of normal for age;
* renal dysfunction: serum creatinine level \>=3x upper limit of normal for age;
* positive serology for human immunodeficiency virus (HIV), active hepatite C or B;
* pregnancy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-02-17
1 organization
1 product
1 drug
2 indications
Product
CD19 CAR-T-cellsIndication
B-cell Acute Lymphoblastic LeukemiaIndication
B-Cell LymphomaDrug
Tocilizumab