Acute Lymphoblastic LeukemiaPhase 1/2NCT07072494
CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-ALL Ineligible for Allogeneic HSCT: A Clinical Study
A Phase 1/2 study testing CD19 CAR-T cells injection in people with Acute Lymphoblastic Leukemia, run by Zhujiang Hospital at 2 sites in China.
Trial summary
This clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- CD19 CAR-T cells injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 19 Jul 2025to 19 Aug 2027
- Phase
- Phase 1/2
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The subject has voluntarily agreed to participate, signed the informed consent form, and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
- The subject has been clinically diagnosed with newly diagnosed or refractory/relapsed B-cell acute lymphoblastic leukemia (B-ALL), including Burkitt lymphoma leukemia and blast-phase chronic myeloid leukemia, and has achieved complete remission (defined as <5% bone marrow blasts, no peripheral blood blasts, and no extramedullary leukemia) after chemotherapy or immunotherapy, but is either ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT), lacks a suitable donor, or declines transplantation.
- Aged between 14 and 80 years (inclusive), male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- At the time of screening, leukemia cells in the bone marrow or peripheral blood must be confirmed as CD19-positive by flow cytometry at initial or relapse diagnosis.
- An expected survival of more than three months from the date of signing the informed consent form.
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- Satisfactory liver, kidney, cardiac, and pulmonary function, defined as:
- Creatinine ≤2× upper limit of normal (ULN);
- Left ventricular ejection fraction (LVEF) ≥50%;
- Blood oxygen saturation >92%;
- Total bilirubin ≤2× ULN; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× ULN.
- Adequate venous access for cell collection and meeting the following hematologic criteria:
- Hemoglobin ≥80 g/L Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L Platelet count ≥75 × 10⁹/L If the above criteria are not met, the investigator may determine eligibility for mononuclear cell collection.
- Female subjects of childbearing potential must have a negative serum pregnancy test (women who have undergone surgical sterilization or have been postmenopausal for at least two years are considered non-fertile). Male and female subjects of reproductive potential must agree to use contraception during the study.
Who cannot join
- Presence of mixed-lineage leukemia or biphenotypic leukemia.
- Prior treatment with CAR-T cell therapy before screening or conditioning.
- Patients with bone marrow failure syndromes associated with genetic disorders, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.
- Any of the following viral infections:
- Hepatitis B virus (HBV) DNA detectable above the lower limit of quantification. Positive hepatitis C virus antibody (HCV-Ab). Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA detectable above the lower limit of quantification.
- Positive human immunodeficiency virus (HIV) antibody test.
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- History of or current malignancy within the past five years (excluding patients with a low risk of recurrence after curative treatment and more than five years of follow-up, as determined by the investigator).
- Any of the following cardiac conditions:
- New York Heart Association (NYHA) Class III or IV congestive heart failure. Severe arrhythmia requiring treatment or clinically significant conduction abnormalities on ECG, including QTc interval ≥480 ms (QTcB = QT/√RR).
- Uncontrolled hypertension despite standard treatment (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥100 mmHg) or pulmonary hypertension.
- Unstable angina. Myocardial infarction, coronary artery bypass grafting, or stent placement within six months before cell infusion.
- Clinically significant valvular heart disease. Other cardiac diseases deemed inappropriate for study participation by the investigator.
- Uncontrolled epilepsy, a history of cerebrovascular ischemia/hemorrhage, cerebellar disease, or other active central nervous system (CNS) disorders.
- Clinically significant pericardial or pleural effusion at screening.
- History of deep vein thrombosis or pulmonary embolism within six months before screening.
- Known hypersensitivity to any component of the study treatment.
- Live vaccine administration within six weeks before screening.
- Severe, uncontrolled, active infection at screening.
- Participation in other interventional clinical trials and receipt of an investigational agent, including:
- An unapproved investigational drug within three months before cell infusion. A marketed drug within fewer than five half-lives before cell infusion.
- Any other conditions deemed unsuitable for study participation by the investigator.
- Physical or cognitive conditions that impair the ability to provide informed consent or comply with study procedures, or unwillingness or inability to adhere to study requirements.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510200
Sanfang Tu, 86 13430200803, doctortutu@163.com
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510200
Sanfang Tu, Doctor, 86 13430200803, doctortutu@163.com
About this study
Official title: Clinical Study on the Efficacy and Safety of CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-Lymphoblastic Leukemia Who Are Ineligible for Allogeneic Hematopoietic Stem Cell Transplantation
This clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions, or the absence of a suitable donor. For these individuals, CD19 CAR-T cell therapy is being evaluated as a potential consolidation therapy.
Read the detailed description
This is an open-label, single-arm, prospective clinical study designed to evaluate the clinical effectiveness and safety of CD19-directed chimeric antigen receptor T (CAR-T) cell therapy as a consolidation treatment in adolescent and adult patients with acute B-ALL who are ineligible for allogeneic HSCT. The study is planned to be conducted over a period of three years, enrolling a total of 30 participants.The primary objective of this study is to assess the clinical effectiveness of CD19 CAR-T cell therapy as a consolidation therapy in achieving remission and improving survival outcomes in the specified patient population. Specifically, the study aims to:
Evaluate the efficacy of CD19 CAR-T cell therapy in achieving complete remission (CR) or minimal residual disease-negative (MRD-) status in patients with B-ALL.
Assess the safety and tolerability of the treatment, with a focus on key adverse events.
Eligible participants will receive CD19 CAR-T cell infusion following a standard lymphodepleting chemotherapy regimen. After infusion, patients will be closely monitored for both short-term and long-term outcomes. Safety Considerations:
Patients will be closely monitored for treatment-related toxicities. Early intervention strategies for CRS and neurotoxicity will be implemented as per established management guidelines. Supportive care, including corticosteroids and anti-cytokine therapies, will be available for severe toxicities.
This study seeks to provide valuable clinical evidence regarding the use of CD19 CAR-T cell therapy as a consolidation strategy for B-ALL patients who are not candidates for HSCT. By evaluating both efficacy and safety parameters, the study aims to contribute to the growing body of knowledge surrounding CAR-T therapies in hematologic malignancies.
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- CD19 CAR-T cells injection
- Keywords
- Chimeric Antigen Receptor T-Cell Immunotherapy, CD19, Acute Lymphoblastic Leukemia
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-T cells injectionDrug
Lymphodepleting pre-treatment will begin one week before the CAR-T cell infusion to reduce the burden of abnormal immune cells in the body, creating a favorable environment for the infused CAR-T cells. The suggested pre-treatment regimen is based on the FC regimen (Fludarabine + Cyclophosphamide).After the pre-treatment, patients will undergo CAR-T cell infusion, where the genetically modified T-cells are infused back into the patient's body.
| Study group | Role | What they receive |
|---|---|---|
| Consolidation therapy with CAR-T cells was performed after induced remission | Experimental | For autologous intravenous infusion only, the recommended dose is 0.5×108 CAR-T live cells, and the dose range is 0.25~0.5×108 CAR-T live cells (±20%, i.e. 0.2-0.6×108 CAR-T live cells) Receives: Drug: CD19 CAR-T cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukemia-Free Survival(LFS)
Relapse defined by ≥ BM blasts(ELN 2022)
Measured: From Chimeric Antigen Receptor T-Cell infusion to relapse or death, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start19 Jul 2025 (estimated)
- Primary completion19 Mar 2027 (estimated)
- Study completion19 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Zhujiang 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072494
- Sponsor's protocol ID
- 2024-KY-394-01
- Status last verified
- Feb 2025
- First submitted
- 24 Mar 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Efficacy and Safety of CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-Lymphoblastic Leukemia Who Are Ineligible for Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07072494
- Acronym / sponsor ID
- 2024-KY-394-01
- Conditions
- Acute Lymphoblastic Leukemia
- Keywords
- Chimeric Antigen Receptor T-Cell Immunotherapy, CD19, Acute Lymphoblastic Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 19 Jul 2025 (estimated)
- Primary completion
- 19 Mar 2027 (estimated)
- Study completion
- 19 Aug 2027 (estimated)
- First posted
- 18 Jul 2025 (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 clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions, or the absence of a suitable donor. For these individuals, CD19 CAR-T cell therapy is being evaluated as a potential consolidation therapy.
Detailed description
This is an open-label, single-arm, prospective clinical study designed to evaluate the clinical effectiveness and safety of CD19-directed chimeric antigen receptor T (CAR-T) cell therapy as a consolidation treatment in adolescent and adult patients with acute B-ALL who are ineligible for allogeneic HSCT. The study is planned to be conducted over a period of three years, enrolling a total of 30 participants.The primary objective of this study is to assess the clinical effectiveness of CD19 CAR-T cell therapy as a consolidation therapy in achieving remission and improving survival outcomes in the specified patient population. Specifically, the study aims to:
Evaluate the efficacy of CD19 CAR-T cell therapy in achieving complete remission (CR) or minimal residual disease-negative (MRD-) status in patients with B-ALL.
Assess the safety and tolerability of the treatment, with a focus on key adverse events.
Eligible participants will receive CD19 CAR-T cell infusion following a standard lymphodepleting chemotherapy regimen. After infusion, patients will be closely monitored for both short-term and long-term outcomes. Safety Considerations:
Patients will be closely monitored for treatment-related toxicities. Early intervention strategies for CRS and neurotoxicity will be implemented as per established management guidelines. Supportive care, including corticosteroids and anti-cytokine therapies, will be available for severe toxicities.
This study seeks to provide valuable clinical evidence regarding the use of CD19 CAR-T cell therapy as a consolidation strategy for B-ALL patients who are not candidates for HSCT. By evaluating both efficacy and safety parameters, the study aims to contribute to the growing body of knowledge surrounding CAR-T therapies in hematologic malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consolidation therapy with CAR-T cells was performed after induced remission | Experimental | Drug: CD19 CAR-T cells injectionFor autologous intravenous infusion only, the recommended dose is 0.5×108 CAR-T live cells, and the dose range is 0.25~0.5×108 CAR-T live cells (±20%, i.e. 0.2-0.6×108 CAR-T live cells) |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- The subject has voluntarily agreed to participate, signed the informed consent form, and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.
- The subject has been clinically diagnosed with newly diagnosed or refractory/relapsed B-cell acute lymphoblastic leukemia (B-ALL), including Burkitt lymphoma leukemia and blast-phase chronic myeloid leukemia, and has achieved complete remission (defined as <5% bone marrow blasts, no peripheral blood blasts, and no extramedullary leukemia) after chemotherapy or immunotherapy, but is either ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT), lacks a suitable donor, or declines transplantation.
- Aged between 14 and 80 years (inclusive), male or female.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- At the time of screening, leukemia cells in the bone marrow or peripheral blood must be confirmed as CD19-positive by flow cytometry at initial or relapse diagnosis.
Key exclusion criteria (22 listed)
- Presence of mixed-lineage leukemia or biphenotypic leukemia.
- Prior treatment with CAR-T cell therapy before screening or conditioning.
- Patients with bone marrow failure syndromes associated with genetic disorders, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.
- Any of the following viral infections:
- Hepatitis B virus (HBV) DNA detectable above the lower limit of quantification. Positive hepatitis C virus antibody (HCV-Ab). Epstein-Barr virus (EBV) or cytomegalovirus (CMV) DNA detectable above the lower limit of quantification.
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 |
|---|---|---|
| CD19 CAR-T cells injectionLymphodepleting pre-treatment will begin one week before the CAR-T cell infusion to reduce the burden of abnormal immune cells in the body, creating a favorable environment for the infused CAR-T cells. The suggested pre-treatment regimen is based on the FC regimen (Fludarabine + Cyclophosphamide).After the pre-treatment, patients will undergo CAR-T cell infusion, where the genetically modified T-cells are infused back into the patient's body. | Drug | Consolidation therapy with CAR-T cells was performed after induced remission |
Primary outcome
Leukemia-Free Survival(LFS)
Time frame: From Chimeric Antigen Receptor T-Cell infusion to relapse or death, assessed up to 12 months
Relapse defined by ≥ BM blasts(ELN 2022)
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 18 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD19 CAR-T cells injection in people with Acute Lymphoblastic Leukemia, run by Zhujiang Hospital at 2 sites in China.
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 14 inclusion and 22 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 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 combined 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.
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 Sanfang Tu, Doctor (86 13430200803, doctortutu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leukemia-Free Survival(LFS) (time frame: From Chimeric Antigen Receptor T-Cell infusion to relapse or death, assessed up to 12 months). 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 18 Jul 2025.