B-cell Acute Lymphoblastic LeukemiaNCT06343090
Clinical Trial of CD19 and CD22 CAR Sequential Therapy Versus Single CD19 CAR Bridging to HSCT for r/r B-ALL Patients
A study testing CD19 CAR T-cell, CD22 CAR T cells and hematopoietic stem-cell transplantation in people with B-cell Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Beijing GoBroad Hospital at 1 site in China.
Trial summary
This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2)… Read more about this study
- Who is it for?
- Ages 1 year to 70 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoid Leukemia
- What is being tested?
- CD19 CAR T-cell, CD22 CAR T cells and hematopoietic stem-cell transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2024to 30 Sep 2043
- Phase
- Interventional
- 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 1 year to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only patients who meet all the following criteria can be included in the group:
- Patients who were diagnosed as primary refractory or relapsed B-ALL. (Criterion-reference: NCCN, version 2.2023); All the patients matched the diagnostic criteria of ALL according to the NCCN guideline (≥20% bone marrow lymphoblasts on hematopathology review of bone marrow aspirate and biopsy materials, which were confirmed by comprehensive flow cytometric immunophenotyping, minimal residual disease analysis and karyotyping of G-banded metaphase chromosomes). Molecular characterization could be obtained via interphase fluorescence in situ hybridization (FISH) testing, reverse transcriptase polymerase chain reaction (RT-PCR) testing, comprehensive testing by next-generation sequencing (NGS) for gene fusions and pathogenic mutations, etc. Determination of the World Health Organization ALL subtypes and cytogenetic and clinical risk groups were also allowed. B-ALL patients who did not achieve a complete remission after previous therapy (including the various treatment response scenarios shown in Table 1), who did not achieve a complete remission after at least two lines of TKI agents (including the various treatment response scenarios shown in Table 1), or who had ≥1 relapses were defined as having refractory or relapsed disease. Patients who were diagnosed as CD19- and CD22-positive high-risk B-ALL with continuous positive minimal residual disease (MRD) for more than three months after last therapy were also eligible. Patients had positive CD19 and CD22 expression on leukemia blasts by FCM (>80% CD19 and CD22 positive);
- Age from 1 to 70 years old;
- No serious allergic constitution;
- Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) score 0 to 2;
- Have life expectancy of at least 60 days based on investigator's judgement;
- Voluntary informed consent is signed by self-aware patients aged 8-70 years and by legal representatives (guardians) of pediatric patients under 18 years of age.
Who cannot join
- Patients with at least one of the following conditions are excluded:
- Intracranial hypertension or unconscious;
- Acute heart failure or severe arrhythmia;
- Acute respiratory failure;
- Other types of malignant tumors;
- Diffuse intravascular coagulation;
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- Serum creatinine and/or blood urea nitrogen over 1.5 times the normal value;
- Sepsis or other uncontrolled infection;
- Uncontrolled diabetes mellitus;
- Severe psychological disorder;
- Obvious cranial lesions by cranial MRI;
- More than 20 leukemic cells/μL in cerebrospinal fluid;
- More than 30% leukemic cells in the peripheral blood;
- Organ recipients;
- Pregnant or breastfeeding;
- Active, uncontrolled infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) or treponema pallidum (TP).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206
Tengyu Wang, 86+18333186020, tengyu.wang@gohealtharo.com
About this study
Official title: Pragmatic Clinical Trial of CD19 and CD22 CAR T-cell Sequential Therapy Versus Single CD19 CAR T-cell Bridging to Transplantation for Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia
This is a multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoid Leukemia
- Being tested
- CD19 CAR T-cell, CD22 CAR T cells, hematopoietic stem-cell transplantation
- Medical subject headings
- Burkitt Lymphoma, 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-cellDrug
Murine-derived CD19 CAR T cells
CD22 CAR T cellsDrug
humanized CD22 CAR T cells
hematopoietic stem-cell transplantationProcedure or surgery
allo-HSCT
| Study group | Role | What they receive |
|---|---|---|
| Arm-1: CD19 CAR T and CD22 CAR T-cell sequential treatments (Sequential CAR) | Experimental | Not described Receives: Drug: CD19 CAR T-cell; Drug: CD22 CAR T cells |
| Arm-2: CD19 CAR T-cell treatment bridging to HSCT (CAR+HSCT) | Experimental | Not described Receives: Drug: CD19 CAR T-cell; Procedure: hematopoietic stem-cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group)
Event-free survival (EFS) of children and adolescent and young adult (AYA) with r/r B-ALL treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT.
EFS is defined as the time from CD19 CAR T-cell infusion to the earliest relapse, death from any cause, or treatment failure.
Measured: 2-year EFS rate
Secondary outcomes (9)
ORR in Sequential CAR group and CAR+HSCT group
Overall response rate (ORR) includes minimal residual disease-negative CR, CRh, CRi, MLFS, aplastic marrow for blood and bone marrow; central nervous system (CNS) remission; CR for lymphomatous extramedullary disease at 3 months (± 1 week) post CD19 CAR T-cell infusion in patients treated by CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT.
Measured: 3 months (± 1 week) ORR
DOR in Sequential CAR group and CAR+HSCT group
Duration of remission (DOR) of children and AYA with r/r B-ALL treated by CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT.
DOR is defined as the time interval from the earliest qualifying minimal residual disease-negative response [i.e. CR, CRh, CRi, MLFS, or aplastic marrow (patients with blood and bone marrow disease), CNS remission (patients with CNS disease) and complete resolution of the lymphomatous enlargement by CT or PET-CT negative (for patients with a previous positive PET-CT) (patients with lymphomatous extramedullary disease)] to the date of relapse or death from any cause.
Measured: from enrollment to the end of treatment at 15 years
OS in Sequential CAR group and CAR+HSCT group
Overall survival (OS) of children and AYA with r/r B-ALL treated by CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT.
OS is defined as the time from CD19 CAR T-cell infusion to death from any cause.
Measured: from enrollment to the end of treatment at 15 years
Adverse events (AEs) in Sequential CAR group and CAR+HSCT group
Total number, incidence and severity of adverse events (AEs) in patients of CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
Measured: from enrollment to the end of treatment at 2 years
Levels of CD19 and CD22 CAR-T cells in Sequential CAR group
The levels of CD19 and CD22 CAR-T cells in peripheral blood from patients treated by CD19 CAR and CD22 CAR T cell sequential infusions will be measured by flow cytometry.
Measured: from CD19 CAR T-cell infusion to the end of treatment at 15 years
Levels of CD19 CAR-T cells in CAR+HSCT group
The levels of CD19 CAR-T cells in peripheral blood from patients in CAR+HSCT group will be measured by flow cytometry.
Measured: from CD19 CAR T-cell infusion to the end of treatment at 15 years
Levels of CD19 and CD22 CAR transgene in Sequential CAR group
The levels of CD19 and CD22 CAR transgene in peripheral blood from patients treated by CD19 CAR and CD22 CAR T cell sequential infusions will be measured by quantitative polymerase chain reaction (qPCR).
Measured: from CD19 CAR T-cell infusion to the end of treatment at 15 years
Levels of CD19 CAR transgene in CAR+HSCT group
The levels of CD19 CAR transgene in peripheral blood from patients in CAR+HSCT group will be measured by quantitative polymerase chain reaction (qPCR).
Measured: from CD19 CAR T-cell infusion to the end of treatment at 15 years
Quantification of B cells in Sequential CAR group and CAR+HSCT group
Quantification of B cells in peripheral blood from patients treated by CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT will be measured by complete blood count and flow cytometry.
Measured: from enrollment to the end of treatment at 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start12 Apr 2024
- Primary completion1 Dec 2042 (estimated)
- Study completion30 Sep 2043 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- a prospective cohort study
- Masking
- None (open label)
- Enrolment
- 353 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The General Hospital of Western Theater Command, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Liquan Hospital, Ruijin Hospital, Central People's Hospital of Zhanjiang, First Affiliated Hospital of Guangxi Medical University
- Responsible party
- Principal investigator, Jing Pan, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343090
- Sponsor's protocol ID
- BJGBYY-IIT-LCYJ-2023-003
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2024
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Clinical Trial of CD19 and CD22 CAR T-cell Sequential Therapy Versus Single CD19 CAR T-cell Bridging to Transplantation for Patients With Refractory or Relapsed B-cell Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT06343090
- Acronym / sponsor ID
- BJGBYY-IIT-LCYJ-2023-003
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Acute Lymphoblastic Leukemia, in Relapse, Refractory Acute Lymphoid Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 353 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- The General Hospital of Western Theater Command, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Liquan Hospital, Ruijin Hospital, Central People's Hospital of Zhanjiang, First Affiliated Hospital of Guangxi Medical University
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 1 Dec 2042 (estimated)
- Study completion
- 30 Sep 2043 (estimated)
- First posted
- 2 Apr 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 multi-center, open-label, non-randomized, two-arm, non-inferior trial. Patients with r/r B-ALL would be assigned to the CD19 CAR and CD22 CAR T-cell sequential infusion group (Sequential CAR, Arm-1) and the CD19 CAR T-cell infusion bridging to hematopoietic stem cell transplantation group (CAR+HSCT, Arm-2), according their own discretion. Patients would be also allowed to assigned to the CD19 CAR T-cell infusion without consolidation therapies group (Single CAR, additional placebo arm) according their own discretion. The primary objective is to prospectively evaluate and compare the efficacy of CD19 CAR and CD22 CAR T cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT in the treatment of r/r B-ALL. The primary endpoint is event-free survival of children and adolescent and young adult (AYA) with r/r B-ALL a treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. A total number of 353 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Arm-1: CD19 CAR T and CD22 CAR T-cell sequential treatments (Sequential CAR) | Experimental | Drug: CD19 CAR T-cell, Drug: CD22 CAR T cells |
| Arm-2: CD19 CAR T-cell treatment bridging to HSCT (CAR+HSCT) | Experimental | Drug: CD19 CAR T-cell, Procedure: hematopoietic stem-cell transplantation |
Who may qualify
- Ages
- 1 year to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Only patients who meet all the following criteria can be included in the group:
Key exclusion criteria (16 listed)
- Patients with at least one of the following conditions are excluded:
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-cellMurine-derived CD19 CAR T cells | Drug | Arm-1: CD19 CAR T and CD22 CAR T-cell sequential treatments (Sequential CAR), Arm-2: CD19 CAR T-cell treatment bridging to HSCT (CAR+HSCT) |
| CD22 CAR T cellshumanized CD22 CAR T cells | Drug | Arm-1: CD19 CAR T and CD22 CAR T-cell sequential treatments (Sequential CAR) |
| hematopoietic stem-cell transplantationallo-HSCT | Procedure or surgery | Arm-2: CD19 CAR T-cell treatment bridging to HSCT (CAR+HSCT) |
Primary outcome
EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group)
Time frame: 2-year EFS rate
Event-free survival (EFS) of children and adolescent and young adult (AYA) with r/r B-ALL treated with CD19 CAR and CD22 CAR T-cell sequential infusions and CD19 CAR T-cell infusion bridging to HSCT. EFS is defined as the time from CD19 CAR T-cell infusion to the earliest relapse, death from any cause, or treatment failure.
9 secondary outcomes
ORR in Sequential CAR group and CAR+HSCT group
Time frame: 3 months (± 1 week) ORR
DOR in Sequential CAR group and CAR+HSCT group
Time frame: from enrollment to the end of treatment at 15 years
OS in Sequential CAR group and CAR+HSCT group
Time frame: from enrollment to the end of treatment at 15 years
Adverse events (AEs) in Sequential CAR group and CAR+HSCT group
Time frame: from enrollment to the end of treatment at 2 years
Levels of CD19 and CD22 CAR-T cells in Sequential CAR group
Time frame: from CD19 CAR T-cell infusion to the end of treatment at 15 years
Levels of CD19 CAR-T cells in CAR+HSCT group
Time frame: from CD19 CAR T-cell infusion to the end of treatment at 15 years
Levels of CD19 and CD22 CAR transgene in Sequential CAR group
Time frame: from CD19 CAR T-cell infusion to the end of treatment at 15 years
Levels of CD19 CAR transgene in CAR+HSCT group
Time frame: from CD19 CAR T-cell infusion to the end of treatment at 15 years
Quantification of B cells in Sequential CAR group and CAR+HSCT group
Time frame: from enrollment to the end of treatment at 15 years
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 10 Mar 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD19 CAR T-cell, CD22 CAR T cells and hematopoietic stem-cell transplantation in people with B-cell Acute Lymphoblastic Leukemia and Acute Lymphoblastic Leukemia, in Relapse, run by Beijing GoBroad Hospital at 1 site 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 7 inclusion and 16 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 10 Mar 2026. 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 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.
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 Tengyu Wang (86+18333186020, tengyu.wang@gohealtharo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFS in CD19 CAR and CD22 CAR-T sequential infusion (Sequential CAR group) and CD19 CAR T-cell infusion bridging to HSCT (CAR+HSCT group) (time frame: 2-year EFS rate). 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 10 Mar 2026.