Actively Recruiting
CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
Led by Institute of Hematology and Blood Transfusion, Czech Republic · Updated on 2025-01-06
10
Participants Needed
1
Research Sites
236 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
CONDITIONS
Official Title
CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with refractory or relapsing CD19 positive B-ALL or B-NHL as defined by treatment refractoriness or relapse status
- CD19 expression confirmed on malignant cells by flow cytometry or immunohistochemistry
- Age between 18 and 80 years
- Ability to understand and sign informed consent
- Women of child-bearing potential must have a negative pregnancy test at enrollment and Visit 1
You will not qualify if you...
- Known hypersensitivity to any component of the investigational medicinal product
- Autologous or allogeneic hematopoietic cell transplantation within 3 months prior to treatment
- Severe, uncontrolled active infection
- Life expectancy less than 6 weeks
- Parenchymal central nervous system involvement
- Respiratory insufficiency requiring oxygen therapy
- Significant liver impairment (bilirubin > 50 µmol/L, AST or ALT > 4 times upper limit)
- Acute kidney injury with serum creatinine > 180 µmol/L, oliguria, or need for dialysis
- Heart failure with ejection fraction less than 30%
- Active grade 3-4 acute graft-versus-host disease
- Serious uncontrolled neurological comorbidity
- Vaccination with live virus vaccines within 4 weeks before or 90 days after treatment
- Pregnancy or breastfeeding
- Fertile subjects not willing to use highly effective contraception during the study
- Positive tests for HIV1/2, Hepatitis B/C, or syphilis
- Recent therapies before cell collection or treatment as specified in protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Transfusion, Czech Republic
Prague, Czechia, 12800
Actively Recruiting
Research Team
J
Jan Vydra
CONTACT
P
Petr Lesny
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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