NCT05054257 CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
| NCT ID | NCT05054257 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Institute of Hematology and Blood Transfusion, Czech Republic |
| Condition | Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2021-06-02 |
| Primary Completion | 2025-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2021-06-02 with a primary completion date of 2025-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
Eligibility Criteria
Inclusion Criteria: 1. Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as: 1. B-ALL refractory to treatment or in the second or subsequent relapse (hematological OR molecular), OR 2. B-NHL refractory to treatment or in first relapse ineligible for autologous stem cell transplantation (ASCT) or in second to fourth relapse, OR 3. B-ALL or B-NHL relapsing after autologous or allogeneic hematopoietic cell transplantation (HCT). 2. CD19 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry. 3. Age ≥18 years and ≤ 80 yearss. 4. Patient able to understand and sign informed consent. 5. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1. General Exclusion Criteria: 1. Known hypersensitivity to any component of the Investigational Medicinal Product (IMP). 2. Autologous or allogeneic HCT in 3 months prior to IMP administration. 3. Severe, uncontrolled active infection. 4. Life expectancy \< 6 weeks. 5. Parenchymal central nervous system involvement. 6. Respiratory insufficiency (need for oxygen therapy). 7. Significant liver impairment: bilirubin \> 50 µmol/L, AST or ALT \> 4times normal upper limit. 8. Acute kidney injury with serum creatinine \> 180 µmol/L, oliguria or need for acute dialysis. 9. Heart failure with EF \< 30% by echocardiography. 10. Presence of active grade 3-4 acute GvHD. 11. Serious uncontrolled neurological comorbidity. 12. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose. 13. Women: pregnancy or breast-feeding. 14. 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 criteria to Procurement of IMP manufacture starting material 1. Severe uncontrolled active infection. 2. Positive test results for HIV1/2, Hepatitis B/C and lues. 3. 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 1. Severe, uncontrolled active infections. 2. Life expectancy \< 6 weeks. 3. Parenchymal central nervous system involvement 4. Respiratory insufficiency (need for oxygen therapy). 5. Significant liver impairment: bilirubin \> 50 µmol/L, Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 4times normal upper limit. 6. Acute kidney injury with serum creatinine \> 180 µg/L, oliguria or need for acute dialysis. 7. Heart failure with Ejection Fraction (EF) \< 30% by echocardiography. 8. Presence of active grade 3 - 4 acute GvHD 9. Serious uncontrolled neurological comorbidity.
Contact & Investigator
Petr Lesny
STUDY CHAIR
Institute of Hematology and Blood Transfusion, Czech Republic
Frequently Asked Questions
Who can join the NCT05054257 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05054257 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05054257 currently recruiting?
Yes, NCT05054257 is actively recruiting participants. Contact the research team at jan.vydra@uhk.cz for enrollment information.
Where is the NCT05054257 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT05054257 clinical trial?
NCT05054257 is sponsored by Institute of Hematology and Blood Transfusion, Czech Republic. The principal investigator is Petr Lesny at Institute of Hematology and Blood Transfusion, Czech Republic. The trial plans to enroll 10 participants.
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