Tests CAR19 T cells in adults with relapsed blood cancers
Tests patient-derived CAR19 T cells in adults with relapsed or refractory leukemia or lymphoma.
Plain-language title generated from the registry record
Registry title: CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
Key facts
- Where
- Prague, CzechiaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT05054257, who can take part
Where in Czechia
- Institute of Hematology and Blood TransfusionPrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Hematology and Blood Transfusion, Czech Republic
- Trial code
- NCT05054257EU 2024-510815-30-00
- Record updated
- 6 January 2025
- Original description
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.Read full original descriptionShow less
Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor-modified Autologous T Cells (CART19) in Patients with Relapsed/refractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. a Dose Escalation, Open-label, Phase I Study.
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
Inclusion: Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:; B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR; B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR; B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT); CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry; Age ≥18 years and ≤ 80 yearss; Patient able to understand and sign informed consent; Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1; General Exclusion Criteria:; Known hypersensitivity to any component of the Investigational Medicinal Product (IMP); Autologous or allogeneic HCT in 3 months prior to IMP administration; Severe, uncontrolled active infection; Life expectancy < 6 weeks; Parenchymal central nervous system involvement; Respiratory insufficiency (need for oxygen therapy); Significant liver impairment: bilirubin > 50 µmol/L, AST or ALT > 4times normal upper limit; Acute kidney injury with serum creatinine > 180 µmol/L, oliguria or need for acute dialysis; Heart failure with EF < 30% by echocardiography; Presence of active grade 3-4 acute GvHD; Serious uncontrolled neurological comorbidity; Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose; Women: pregnancy or breast-feeding; Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:; female patients of childbearing potential not willing to use a highly effective method of contraception during the study,; male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.
Exclusion: Severe uncontrolled active infection; Positive test results for HIV1/2, Hepatitis B/C and lues; Severe, uncontrolled active infections; Respiratory insufficiency (need for oxygen therapy); Concurrent or recent prior therapies before apheresis:; Autologous or allogeneic hematopoietic cell transplantation within 12 weeks; Clofarabine, Fludarabine, Alemtuzumab within 8 weeks; Donor lymphocyte infusions within 4 weeks; Pegylated asparaginase within 4 weeks; Maintenance chemotherapy within 2 weeks; Long-acting Granulocyte Colony Stimulating Factor (G-CSF) within 2 weeks; Vincristine within 2 weeks; Intrathecal methotrexate within 1 week; Granulocyte Colony Stimulating Factor (G-CSF) within 5 days; Therapeutic dose of corticosteroids within 3 days; Short-acting cytostatics within 3 days; Significant liver impairment: bilirubin > 50 µmol/L, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 4times normal upper limit; Acute kidney injury with serum creatinine > 180 µg/L, oliguria or need for acute dialysis; Heart failure with Ejection Fraction (EF) < 30% by echocardiography; Life expectancy < 6 weeks; Parenchymal central nervous system involvement; Presence of active grade 3 - 4 acute GvHD; Serious uncontrolled neurological comorbidity.