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New treatment option for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Official title CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT05054257
What this study is testing
What is Autologous CAR19 T lymphocytes?
Autologous CAR19 T lymphocytes is an investigational medicine, being studied as a potential treatment for relapsed or refractory b-cell acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility criteria
- 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
- 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.
- people 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 criteria to Procurement of IMP manufacture...
- Severe uncontrolled active infection.
- Positive test results for HIV1/2, Hepatitis B/C and lues.
- 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 Exclusion criteria to IMP administration
- Severe, uncontrolled active infections.
- Life expectancy \< 6 weeks.
- Parenchymal central nervous system involvement
- Respiratory insufficiency (need for oxygen therapy).
- 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.
- Presence of active grade 3 - 4 acute GvHD
- Serious uncontrolled neurological comorbidity.
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.