Relapsed or Refractory B-cell Acute Lymphoblastic LeukemiaPhase 1UHKT-CAR19-01NCT05054257
CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma
A Phase 1 study testing Autologous CAR19 T lymphocytes in people with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma Refractory, run by Institute of Hematology and Blood Transfusion, Czech Republic at 1 site in Czechia.
Trial summary
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma Refractory, Non-Hodgkin's Lymphoma, Relapsed
- What is being tested?
- Autologous CAR19 T lymphocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 2 Jun 2021to 12 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 criteria to Procurement of IMP manufacture starting material
- 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
Who cannot join
- 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.
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- Heart failure with Ejection Fraction (EF) < 30% by echocardiography.
- Presence of active grade 3 - 4 acute GvHD
- Serious uncontrolled neurological comorbidity.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Institute of Hematology and Blood Transfusion, Czech Republic
Prague, 12800
Jan Vydra, MD, +420 221977182, jan.vydra@uhkt.cz
Petr Lesny, MD, +420221977629, petr.lesny@uhkt.cz
About this study
Official title: 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.
Read the detailed description
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
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma Refractory, Non-Hodgkin's Lymphoma, Relapsed
- Being tested
- Autologous CAR19 T lymphocytes
- Keywords
- B Cell, ALL, Relapsed or Refractory, B-NHL, Leukemia, Chimeric antigen receptor, CAR, CAR T cell
- Medical subject headings
- Recurrence, Burkitt Lymphoma, Lymphoma, Non-Hodgkin, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous CAR19 T lymphocytesDrug
First-in-human trial examining the safety and efficacy of CART19 in r/r B-ALL and B-NHL
| Study group | Role | What they receive |
|---|---|---|
| Autologous CAR19 T lymphocytes | Experimental | Human Autologous T Lymphocytes Expressing the Chimeric Antigen Receptor Specific to CD19 Receives: Drug: Autologous CAR19 T lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Cumulative incidence of IMP-related adverse events (AEs) graded by ASTCT consensus grading criteria for Cytokine Release Syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) and by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 for other AEs. Toxicities will be followed from the start of Blood Collection or Apheresis until the end of the study.
Measured: Up to 2 years post treatment
Assessment of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-limiting toxicities (DLTs) during the first 28 days after IMP administration
Measured: Up to 28 days after IMP administration
Secondary outcomes (3)
Complete remission ( CR) rate
Assessment of the efficacy of IMP cells administration in patients with refractory or relapsed CD19+ NHL and B-ALL evaluated by Complete Remission rate
Measured: CR rate at 100 days and 6 months after IMP administration
Overall Survival
Assessment of the efficacy of IMP cells administration in patients with refractory or relapsed CD19+ NHL and B-ALL evaluated by Overall Survival
Measured: OS at 1 year after IMP administration
Quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire (EORTC QLQ-C30).
EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small. A change of 10 - 20 points is considered a moderate change.
Measured: At 6 months and 1 year following IMP administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start2 Jun 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion12 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Relapsed or Refractory B-cell Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology and Blood Transfusion, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petr Lesny, Study chair, Institute of Hematology and Blood Transfusion, Czech RepublicJan Vydra, Principal investigator, Institute of Hematology and Blood Transfusion, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054257
- Sponsor's protocol ID
- UHKT-CAR19-01
- Other IDs
- 2018-004789-32, 2018
- Acronym
- UHKT-CAR19-01
- Status last verified
- Jan 2025
- First submitted
- 19 Jul 2021
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maude SL, Frey N, Shaw PA, Aplenc R, Barrett DM, Bunin NJ, Chew A, Gonzalez VE, Zheng Z, Lacey SF, Mahnke YD, Melenhorst JJ, Rheingold SR, Shen A, Teachey DT, Levine BL, June CH, Porter DL, Grupp SA. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014 Oct 16;371(16):1507-17. doi: 10.1056/NEJMoa1407222.
PubMed 25317870Porter DL, Hwang WT, Frey NV, Lacey SF, Shaw PA, Loren AW, Bagg A, Marcucci KT, Shen A, Gonzalez V, Ambrose D, Grupp SA, Chew A, Zheng Z, Milone MC, Levine BL, Melenhorst JJ, June CH. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med. 2015 Sep 2;7(303):303ra139. doi: 10.1126/scitranslmed.aac5415.
PubMed 26333935Hartmann J, Schussler-Lenz M, Bondanza A, Buchholz CJ. Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts. EMBO Mol Med. 2017 Sep;9(9):1183-1197. doi: 10.15252/emmm.201607485.
PubMed 28765140Hamada M, Nishio N, Okuno Y, Suzuki S, Kawashima N, Muramatsu H, Tsubota S, Wilson MH, Morita D, Kataoka S, Ichikawa D, Murakami N, Taniguchi R, Suzuki K, Kojima D, Sekiya Y, Nishikawa E, Narita A, Hama A, Kojima S, Nakazawa Y, Takahashi Y. Integration Mapping of piggyBac-Mediated CD19 Chimeric Antigen Receptor T Cells Analyzed by Novel Tagmentation-Assisted PCR. EBioMedicine. 2018 Aug;34:18-26. doi: 10.1016/j.ebiom.2018.07.008. Epub 2018 Aug 3.
PubMed 30082227Tipanee J, VandenDriessche T, Chuah MK. Transposons: Moving Forward from Preclinical Studies to Clinical Trials. Hum Gene Ther. 2017 Nov;28(11):1087-1104. doi: 10.1089/hum.2017.128. Epub 2017 Aug 22.
PubMed 28920716Kebriaei P, Singh H, Huls MH, Figliola MJ, Bassett R, Olivares S, Jena B, Dawson MJ, Kumaresan PR, Su S, Maiti S, Dai J, Moriarity B, Forget MA, Senyukov V, Orozco A, Liu T, McCarty J, Jackson RN, Moyes JS, Rondon G, Qazilbash M, Ciurea S, Alousi A, Nieto Y, Rezvani K, Marin D, Popat U, Hosing C, Shpall EJ, Kantarjian H, Keating M, Wierda W, Do KA, Largaespada DA, Lee DA, Hackett PB, Champlin RE, Cooper LJ. Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells. J Clin Invest. 2016 Sep 1;126(9):3363-76. doi: 10.1172/JCI86721. Epub 2016 Aug 2.
PubMed 27482888Otahal P, Prukova D, Kral V, Fabry M, Vockova P, Lateckova L, Trneny M, Klener P. Lenalidomide enhances antitumor functions of chimeric antigen receptor modified T cells. Oncoimmunology. 2015 Dec 3;5(4):e1115940. doi: 10.1080/2162402X.2015.1115940. eCollection 2016 Apr.
PubMed 27141398Yusa K, Zhou L, Li MA, Bradley A, Craig NL. A hyperactive piggyBac transposase for mammalian applications. Proc Natl Acad Sci U S A. 2011 Jan 25;108(4):1531-6. doi: 10.1073/pnas.1008322108. Epub 2011 Jan 4.
PubMed 21205896Ptackova P, Musil J, Stach M, Lesny P, Nemeckova S, Kral V, Fabry M, Otahal P. A new approach to CAR T-cell gene engineering and cultivation using piggyBac transposon in the presence of IL-4, IL-7 and IL-21. Cytotherapy. 2018 Apr;20(4):507-520. doi: 10.1016/j.jcyt.2017.10.001. Epub 2018 Feb 21.
PubMed 29475789Milone MC, Fish JD, Carpenito C, Carroll RG, Binder GK, Teachey D, Samanta M, Lakhal M, Gloss B, Danet-Desnoyers G, Campana D, Riley JL, Grupp SA, June CH. Chimeric receptors containing CD137 signal transduction domains mediate enhanced survival of T cells and increased antileukemic efficacy in vivo. Mol Ther. 2009 Aug;17(8):1453-64. doi: 10.1038/mt.2009.83. Epub 2009 Apr 21.
PubMed 19384291Riviere I, Sadelain M. Chimeric Antigen Receptors: A Cell and Gene Therapy Perspective. Mol Ther. 2017 May 3;25(5):1117-1124. doi: 10.1016/j.ymthe.2017.03.034. Epub 2017 Apr 26.
PubMed 28456379Norelli M, Casucci M, Bonini C, Bondanza A. Clinical pharmacology of CAR-T cells: Linking cellular pharmacodynamics to pharmacokinetics and antitumor effects. Biochim Biophys Acta. 2016 Jan;1865(1):90-100. doi: 10.1016/j.bbcan.2015.12.001. Epub 2015 Dec 31.
PubMed 26748354Lamers CH, Sleijfer S, van Steenbergen S, van Elzakker P, van Krimpen B, Groot C, Vulto A, den Bakker M, Oosterwijk E, Debets R, Gratama JW. Treatment of metastatic renal cell carcinoma with CAIX CAR-engineered T cells: clinical evaluation and management of on-target toxicity. Mol Ther. 2013 Apr;21(4):904-12. doi: 10.1038/mt.2013.17. Epub 2013 Feb 19.
PubMed 23423337Till BG, Jensen MC, Wang J, Chen EY, Wood BL, Greisman HA, Qian X, James SE, Raubitschek A, Forman SJ, Gopal AK, Pagel JM, Lindgren CG, Greenberg PD, Riddell SR, Press OW. Adoptive immunotherapy for indolent non-Hodgkin lymphoma and mantle cell lymphoma using genetically modified autologous CD20-specific T cells. Blood. 2008 Sep 15;112(6):2261-71. doi: 10.1182/blood-2007-12-128843. Epub 2008 May 28.
PubMed 18509084Porter DL, Levine BL, Kalos M, Bagg A, June CH. Chimeric antigen receptor-modified T cells in chronic lymphoid leukemia. N Engl J Med. 2011 Aug 25;365(8):725-33. doi: 10.1056/NEJMoa1103849. Epub 2011 Aug 10.
PubMed 21830940
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05054257
- Acronym / sponsor ID
- UHKT-CAR19-01 / UHKT-CAR19-01
- Conditions
- Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Non-Hodgkin's Lymphoma Refractory, Non-Hodgkin's Lymphoma, Relapsed
- Keywords
- B Cell, ALL, Relapsed or Refractory, B-NHL, Leukemia, Chimeric antigen receptor, CAR, CAR T cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Hematology and Blood Transfusion, Czech RepublicUniversity, hospital or other
- Study start
- 2 Jun 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 12 Dec 2025 (estimated)
- First posted
- 23 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I Dose Escalation Study of CART19 Cells for Adult Patients With Relapsed / Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous CAR19 T lymphocytes | Experimental | Drug: Autologous CAR19 T lymphocytesHuman Autologous T Lymphocytes Expressing the Chimeric Antigen Receptor Specific to CD19 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (40 listed)
- Patient with refractory or relapsing CD19 positive B-ALL or B-NHL defined as:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous CAR19 T lymphocytesFirst-in-human trial examining the safety and efficacy of CART19 in r/r B-ALL and B-NHL | Drug | Autologous CAR19 T lymphocytes |
Primary outcome
Incidence of adverse events
Time frame: Up to 2 years post treatment
Cumulative incidence of IMP-related adverse events (AEs) graded by ASTCT consensus grading criteria for Cytokine Release Syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) and by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 for other AEs. Toxicities will be followed from the start of Blood Collection or Apheresis until the end of the study.
Assessment of Dose-Limiting Toxicities (DLTs)
Time frame: Up to 28 days after IMP administration
Incidence of Dose-limiting toxicities (DLTs) during the first 28 days after IMP administration
3 secondary outcomes
Complete remission ( CR) rate
Time frame: CR rate at 100 days and 6 months after IMP administration
Overall Survival
Time frame: OS at 1 year after IMP administration
Quality of life using the European Organization for the Research and Treatment of Cancer 30 item questionnaire (EORTC QLQ-C30).
Time frame: At 6 months and 1 year following IMP administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 25317870Maude SL, Frey N, Shaw PA, Aplenc R, Barrett DM, Bunin NJ, Chew A, Gonzalez VE, Zheng Z, Lacey SF, Mahnke YD, Melenhorst JJ, Rheingold SR, Shen A, Teachey DT, Levine BL, June CH, Porter DL, Grupp SA. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014 Oct 16;371(16):1507-17. doi: 10.1056/NEJMoa1407222.
- Background: PubMed 26333935Porter DL, Hwang WT, Frey NV, Lacey SF, Shaw PA, Loren AW, Bagg A, Marcucci KT, Shen A, Gonzalez V, Ambrose D, Grupp SA, Chew A, Zheng Z, Milone MC, Levine BL, Melenhorst JJ, June CH. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med. 2015 Sep 2;7(303):303ra139. doi: 10.1126/scitranslmed.aac5415.
- Background: PubMed 28765140Hartmann J, Schussler-Lenz M, Bondanza A, Buchholz CJ. Clinical development of CAR T cells-challenges and opportunities in translating innovative treatment concepts. EMBO Mol Med. 2017 Sep;9(9):1183-1197. doi: 10.15252/emmm.201607485.
- Background: PubMed 30082227Hamada M, Nishio N, Okuno Y, Suzuki S, Kawashima N, Muramatsu H, Tsubota S, Wilson MH, Morita D, Kataoka S, Ichikawa D, Murakami N, Taniguchi R, Suzuki K, Kojima D, Sekiya Y, Nishikawa E, Narita A, Hama A, Kojima S, Nakazawa Y, Takahashi Y. Integration Mapping of piggyBac-Mediated CD19 Chimeric Antigen Receptor T Cells Analyzed by Novel Tagmentation-Assisted PCR. EBioMedicine. 2018 Aug;34:18-26. doi: 10.1016/j.ebiom.2018.07.008. Epub 2018 Aug 3.
- Background: PubMed 28920716Tipanee J, VandenDriessche T, Chuah MK. Transposons: Moving Forward from Preclinical Studies to Clinical Trials. Hum Gene Ther. 2017 Nov;28(11):1087-1104. doi: 10.1089/hum.2017.128. Epub 2017 Aug 22.
- Background: PubMed 27482888Kebriaei P, Singh H, Huls MH, Figliola MJ, Bassett R, Olivares S, Jena B, Dawson MJ, Kumaresan PR, Su S, Maiti S, Dai J, Moriarity B, Forget MA, Senyukov V, Orozco A, Liu T, McCarty J, Jackson RN, Moyes JS, Rondon G, Qazilbash M, Ciurea S, Alousi A, Nieto Y, Rezvani K, Marin D, Popat U, Hosing C, Shpall EJ, Kantarjian H, Keating M, Wierda W, Do KA, Largaespada DA, Lee DA, Hackett PB, Champlin RE, Cooper LJ. Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells. J Clin Invest. 2016 Sep 1;126(9):3363-76. doi: 10.1172/JCI86721. Epub 2016 Aug 2.
- Background: PubMed 27141398Otahal P, Prukova D, Kral V, Fabry M, Vockova P, Lateckova L, Trneny M, Klener P. Lenalidomide enhances antitumor functions of chimeric antigen receptor modified T cells. Oncoimmunology. 2015 Dec 3;5(4):e1115940. doi: 10.1080/2162402X.2015.1115940. eCollection 2016 Apr.
- Background: PubMed 21205896Yusa K, Zhou L, Li MA, Bradley A, Craig NL. A hyperactive piggyBac transposase for mammalian applications. Proc Natl Acad Sci U S A. 2011 Jan 25;108(4):1531-6. doi: 10.1073/pnas.1008322108. Epub 2011 Jan 4.
- Background: PubMed 29475789Ptackova P, Musil J, Stach M, Lesny P, Nemeckova S, Kral V, Fabry M, Otahal P. A new approach to CAR T-cell gene engineering and cultivation using piggyBac transposon in the presence of IL-4, IL-7 and IL-21. Cytotherapy. 2018 Apr;20(4):507-520. doi: 10.1016/j.jcyt.2017.10.001. Epub 2018 Feb 21.
- Background: PubMed 19384291Milone MC, Fish JD, Carpenito C, Carroll RG, Binder GK, Teachey D, Samanta M, Lakhal M, Gloss B, Danet-Desnoyers G, Campana D, Riley JL, Grupp SA, June CH. Chimeric receptors containing CD137 signal transduction domains mediate enhanced survival of T cells and increased antileukemic efficacy in vivo. Mol Ther. 2009 Aug;17(8):1453-64. doi: 10.1038/mt.2009.83. Epub 2009 Apr 21.
- Background: PubMed 28456379Riviere I, Sadelain M. Chimeric Antigen Receptors: A Cell and Gene Therapy Perspective. Mol Ther. 2017 May 3;25(5):1117-1124. doi: 10.1016/j.ymthe.2017.03.034. Epub 2017 Apr 26.
- Background: PubMed 26748354Norelli M, Casucci M, Bonini C, Bondanza A. Clinical pharmacology of CAR-T cells: Linking cellular pharmacodynamics to pharmacokinetics and antitumor effects. Biochim Biophys Acta. 2016 Jan;1865(1):90-100. doi: 10.1016/j.bbcan.2015.12.001. Epub 2015 Dec 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petr Lesny study chair
Institute of Hematology and Blood Transfusion, Czech Republic
Jan Vydra principal investigator
Institute of Hematology and Blood Transfusion, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous CAR19 T lymphocytes in people with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma Refractory, run by Institute of Hematology and Blood Transfusion, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 40 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Vydra (+420221977182, jan.vydra@uhk.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 2 years post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05054257, which also lists 42 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.