Very High Risk Acute Lymphoblastic LeukemiaPhase 2NCT06247501
Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation
A Phase 2 study testing SNUH-CD19-CAR-T in people with Very High Risk Acute Lymphoblastic Leukemia and CD19 CAR-T Therapy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. Read more about this study
- Who is it for?
- Ages Up to 25 years
- Conditions the study is for
- Very High Risk Acute Lymphoblastic Leukemia, CD19 CAR-T Therapy
- What is being tested?
- SNUH-CD19-CAR-T
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jan 2024to 31 Dec 2029
- Phase
- Phase 2
- 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 Up to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject eligibility criteria include individuals who are under the age of 25 at the time of SNUH-CD19-CAR-T administration. Confirmation of B-cell acute lymphoblastic leukemia diagnosed at the initial assessment by a treating physician for the first diagnosis is required. Immunophenotypic analysis of CD19 expression on leukemia cells must be confirmed through immune profiling at the time of the initial diagnosis of B-cell acute lymphoblastic leukemia. In patients experiencing hematologic relapse of B-cell acute lymphoblastic leukemia, CD19 expression should also be confirmed at the time of relapse confirmation.
- Patients must achieve hematologic complete remission defined as less than 5% blasts in the bone marrow after the first-line or second-line chemotherapy (first salvage therapy). Eligible patients for hematopoietic stem cell transplantation, defined by indications for transplantation, include those meeting at least one of the following criteria:
- Philadelphia chromosome-positive due to t(9;22)(q34;q11) translocation.
- Hypodiploidy defined by fewer than 44 chromosomes.
- E2A-HLF gene fusion due to t(17;19) translocation.
- Detection of minimal residual disease (MRD) positive at 0.01% or higher by next-generation sequencing confirmed after consolidation therapy and maintenance therapy.
- Failure of the first-line therapy.
- Cases not meeting any of the above criteria but deemed eligible for hematopoietic stem cell transplantation based on the investigator's judgment.
Who cannot join
- Patients who have undergone hematopoietic stem cell transplantation.
- Individuals for whom an adequate or sufficient leukapheresis product suitable for the production of SNUH-CD19-CAR-T cannot be obtained or is unavailable.
- Those known to be infected with the human immunodeficiency virus (HIV).
- Presence of uncontrolled active infections, determined by the investigator's assessment. If appropriate treatment has been administered for the infection, and there are no signs of progression at the time of enrollment, it is considered controlled. Persistent fever without other symptoms is not interpreted as progressive infection.
- Women who are pregnant or breastfeeding.
- Individuals deemed clinically inappropriate for participation in the clinical trial based on the investigator's clinical judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Children's Hospital
Seoul
Hyoung Jin Kang
About this study
This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. The trial includes patients aged 25 or younger.
- Being tested
- SNUH-CD19-CAR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNUH-CD19-CAR-TGenetic
CD19 CAR-T is a gene therapy that uses genetically modified autologous peripheral blood T-cells to target CD19 on the surface of B-cells. In this approach using CARs, lymphocytes are genetically manipulated, introducing the chimeric antigen receptor gene into the lymphocytes to combine the function of effector T-cells with antibody-like abilities. The chimeric antigen receptor can recognize cell surface antigens without the need for antigen processing. By using a single-chain variable fragment (scFv) antibody, which combines the variable regions of the heavy chain (VH) and light chain (VL) through a peptide linker of approximately 15 amino acids in length, the CAR gains the ability to bind to tumor antigens.
What is being measured
The primary outcome is the main question the study is designed to answer.
Event free survival
Measured: above 3 year
Secondary outcomes (1)
Overall survival
Measured: above 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start19 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very High Risk Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247501
- Sponsor's protocol ID
- SNUH-CART-CD19-SCT
- Status last verified
- Jan 2024
- First submitted
- 17 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06247501
- Acronym / sponsor ID
- SNUH-CART-CD19-SCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 8 Feb 2024 (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.
This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation. The trial includes patients aged 25 or younger.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Subject eligibility criteria include individuals who are under the age of 25 at the time of SNUH-CD19-CAR-T administration. Confirmation of B-cell acute lymphoblastic leukemia diagnosed at the initial assessment by a treating physician for the first diagnosis is required. Immunophenotypic analysis of CD19 expression on leukemia cells must be confirmed through immune profiling at the time of the initial diagnosis of B-cell acute lymphoblastic leukemia. In patients experiencing hematologic relapse of B-cell acute lymphoblastic leukemia, CD19 expression should also be confirmed at the time of relapse confirmation.
- Patients must achieve hematologic complete remission defined as less than 5% blasts in the bone marrow after the first-line or second-line chemotherapy (first salvage therapy). Eligible patients for hematopoietic stem cell transplantation, defined by indications for transplantation, include those meeting at least one of the following criteria:
- Philadelphia chromosome-positive due to t(9;22)(q34;q11) translocation.
- Hypodiploidy defined by fewer than 44 chromosomes.
- E2A-HLF gene fusion due to t(17;19) translocation.
Key exclusion criteria (6 listed)
- Patients who have undergone hematopoietic stem cell transplantation.
- Individuals for whom an adequate or sufficient leukapheresis product suitable for the production of SNUH-CD19-CAR-T cannot be obtained or is unavailable.
- Those known to be infected with the human immunodeficiency virus (HIV).
- Presence of uncontrolled active infections, determined by the investigator's assessment. If appropriate treatment has been administered for the infection, and there are no signs of progression at the time of enrollment, it is considered controlled. Persistent fever without other symptoms is not interpreted as progressive infection.
- Women who are pregnant or breastfeeding.
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 |
|---|---|---|
| SNUH-CD19-CAR-TCD19 CAR-T is a gene therapy that uses genetically modified autologous peripheral blood T-cells to target CD19 on the surface of B-cells. In this approach using CARs, lymphocytes are genetically manipulated, introducing the chimeric antigen receptor gene into the lymphocytes to combine the function of effector T-cells with antibody-like abilities. The chimeric antigen receptor can recognize cell surface antigens without the need for antigen processing. By using a single-chain variable fragment (scFv) antibody, which combines the variable regions of the heavy chain (VH) and light chain (VL) through a peptide linker of approximately 15 amino acids in length, the CAR gains the ability to bind to tumor antigens. | Genetic | – |
Primary outcome
Event free survival
Time frame: above 3 year
1 secondary outcome
Overall survival
Time frame: above 3 year
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 8 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SNUH-CD19-CAR-T in people with Very High Risk Acute Lymphoblastic Leukemia and CD19 CAR-T Therapy, run by Seoul National University Hospital at 1 site in South Korea.
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 8 inclusion and 6 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 8 Feb 2024. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hyoung Jin Kang, Professor (02-2072-3452, kanghj@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event free survival (time frame: above 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2024.