CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
NCT ID: NCT05054257
Last Updated: 2025-01-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE1
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-06-02
Study Completion Date
2025-12-12
Brief Summary
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Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
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The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma
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Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell Lymphoma
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B-cell Malignancy
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Safety and Efficacy of CD19-Targeted CAR-T Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma
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Detailed Description
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This is an open-label, single arm study on up to 24 adult subjects with refractory or relapsed CD19+ Non-Hodgkin's Lymphoma or B-ALL. Following lymphodepleting conditioning regimen, the patients will receive a single dose of autologous CAR19 T lymphocytes provided by the sponsor´s manufacturing facility. CART19 dose will be escalated in consecutive patients using accelerated titration design in order to establish recommended CART19 dose for further study, which will be either Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD), whichever is reached first.
Conditions
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Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Non-Hodgkin's Lymphoma Refractory
Non-Hodgkin's Lymphoma, Relapsed
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Autologous CAR19 T lymphocytes
Human Autologous T Lymphocytes Expressing the Chimeric Antigen Receptor Specific to CD19
Group Type
EXPERIMENTAL
Autologous CAR19 T lymphocytes
Intervention Type
DRUG
First-in-human trial examining the safety and efficacy of CART19 in r/r B-ALL and B-NHL
Interventions
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Autologous CAR19 T lymphocytes
First-in-human trial examining the safety and efficacy of CART19 in r/r B-ALL and B-NHL
Intervention Type
DRUG
Eligibility Criteria
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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.
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.
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.
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
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.
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.
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
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.
Minimum Eligible Age
18 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Institute of Hematology and Blood Transfusion, Czech Republic
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Petr Lesny
Role: STUDY_CHAIR
Institute of Hematology and Blood Transfusion, Czech Republic
Jan Vydra
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology and Blood Transfusion, Czech Republic
Locations
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Institute of Hematology and Blood Transfusion, Czech Republic
Prague, , Czechia
Site Status
RECRUITING
Countries
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Czechia
Central Contacts
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Facility Contacts
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References
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Reference Type
BACKGROUND
Maude SL, Laetsch TW, Buechner J, Rives S, Boyer M, Bittencourt H, Bader P, Verneris MR, Stefanski HE, Myers GD, Qayed M, De Moerloose B, Hiramatsu H, Schlis K, Davis KL, Martin PL, Nemecek ER, Yanik GA, Peters C, Baruchel A, Boissel N, Mechinaud F, Balduzzi A, Krueger J, June CH, Levine BL, Wood P, Taran T, Leung M, Mueller KT, Zhang Y, Sen K, Lebwohl D, Pulsipher MA, Grupp SA. Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia. N Engl J Med. 2018 Feb 1;378(5):439-448. doi: 10.1056/NEJMoa1709866.
Reference Type
BACKGROUND
Lee DW, Santomasso BD, Locke FL, Ghobadi A, Turtle CJ, Brudno JN, Maus MV, Park JH, Mead E, Pavletic S, Go WY, Eldjerou L, Gardner RA, Frey N, Curran KJ, Peggs K, Pasquini M, DiPersio JF, van den Brink MRM, Komanduri KV, Grupp SA, Neelapu SS. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. Biol Blood Marrow Transplant. 2019 Apr;25(4):625-638. doi: 10.1016/j.bbmt.2018.12.758. Epub 2018 Dec 25.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UHKT-CAR19-01
Identifier Type: -
Identifier Source: org_study_id
2018-004789-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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