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B-cell Acute Lymphoblastic LeukemiaPhase 1/2NCT07575971

Exploratory Study of CD22/CD19 Dual-Target CAR-T Cell Therapy as Consolidation Treatment After First Remission in High-Risk B-Cell Acute Lymphoblastic Leukemia

A Phase 1/2 study testing CD22/CD19 Dual-Target CAR-T Cells in people with B-cell Acute Lymphoblastic Leukemia, run by Liping Dou at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This single-center, open-label, single-arm, prospective study will evaluate the safety, tolerability, and efficacy of CD22/CD19 dual-target chimeric antigen receptor T-cell (CAR-T) therapy as consolidation treatment in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who have achieved first… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
B-cell Acute Lymphoblastic Leukemia
What is being tested?
CD22/CD19 Dual-Target CAR-T Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jan 2026to 31 Dec 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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have provided written informed consent and are willing and able to comply with study procedures, including scheduled visits, treatment, laboratory tests, and other study-related assessments.
  • Patients with cytologically or histologically confirmed B-cell acute lymphoblastic leukemia/lymphoma (B-ALL/LBL) according to WHO 2022 criteria, with CD19-positive and/or CD22-positive disease. Patients must have achieved first morphological complete remission (CR1; bone marrow blasts <5%) after standard induction chemotherapy. Patients may or may not have achieved deep remission, defined as minimal residual disease (MRD) negativity assessed by flow cytometry and/or molecular methods (e.g., quantitative PCR or next-generation sequencing).
  • Patients who are eligible for enhanced consolidation therapy. Patients with high-risk disease defined as:
  • High-risk group based on cytogenetic and molecular features, regardless of MRD status after consolidation; or Standard-risk group with persistent MRD positivity after two cycles of consolidation therapy, indicating a high risk of relapse.
  • In addition, patients are unwilling or ineligible to allogeneic hematopoietic stem cell transplantation, and are planned to receive CAR-T cell therapy as consolidation treatment.
  • Age between 18 and 85 years, regardless of sex.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • Estimated life expectancy ≥3 months.
  • Hemoglobin ≥60 g/L (transfusion allowed).
  • Absolute neutrophil count ≥1,000/μL and platelet count ≥45,000/μL.
  • Adequate organ function, defined as:
  • Total bilirubin ≤1.5 × upper limit of normal (ULN) (except Gilbert's syndrome); ALT and AST ≤2.5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min (Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥50%, no clinically significant arrhythmia, and no pericardial effusion; Baseline oxygen saturation >92% on room air; No clinically significant pleural effusion.
  • Subjects of reproductive potential must agree to use effective contraception from enrollment until at least 6 months after completion of the study. Subjects who are pregnant or suspected to be pregnant must notify the investigator immediately.

Who cannot join

  • Patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL), or with risk factors indicating the need for allogeneic hematopoietic stem cell transplantation (meeting any of the following), who are planned to receive allogeneic hematopoietic stem cell transplantation or CD19/CD3 bispecific antibody (blinatumomab) therapy and refuse CAR-T cell immunotherapy as consolidation treatment, including any of the following conditions:
  • ① Early relapse within 6 months after achieving first complete remission;
  • ② Primary refractory disease, defined as failure to achieve first morphological complete remission after two cycles of standard first-line induction chemotherapy;
  • ③ Failure to achieve complete remission or relapse after first-line or multiple lines of salvage chemotherapy;
  • ④ Relapse after allogeneic hematopoietic stem cell transplantation.
  • Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.
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  • Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.
  • (Active HBV infection is defined as: HBV DNA ≥2000 IU/mL, ALT ≥2×ULN, and exclusion of other causes of hepatitis.)
  • Non-disease-related hepatic or renal dysfunction defined as:
  • ALT or AST >3×ULN; Total bilirubin >2×ULN; Creatinine clearance <30 mL/min.
  • History of significant cardiovascular disease within 12 months prior to enrollment, including myocardial infarction, coronary intervention, unstable angina, or clinically significant arrhythmia.
  • Other severe or uncontrolled medical conditions that may interfere with study participation or outcomes, including but not limited to uncontrolled diabetes, severe gastrointestinal disease, severe cardiopulmonary disease, autoimmune disease, immunodeficiency, or uncontrolled infections.
  • History of severe immediate hypersensitivity reactions to study-related drugs, aminoglycosides, or biologic agents.
  • Pregnant or breastfeeding women.
  • Patients who are unable or unwilling to comply with study procedures or follow-up, or who have poor adherence as judged by the investigator.
  • History of other malignancies unless disease-free for at least 3 years without active treatment (except for adequately treated non-melanoma skin cancer or carcinoma in situ).
  • Receipt of live vaccines within 6 weeks prior to initiation of lymphodepleting chemotherapy.
  • Major surgery within 14 days prior to enrollment or planned major surgery during the study period.
  • Any other condition that, in the investigator's judgment, may increase risk, interfere with study results, or make the patient unsuitable for the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li-Ping Dou, Dr. contact

+8613681207138

lipingruirui@163.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Study on Targeted CD22/CD19 Chimeric Antigen Receptor (CAR)-T Cell Immunotherapy for Enhanced Consolidation Therapy After Initial Remission in High-risk B-cell Acute Lymphoblastic Leukemia

This single-center, open-label, single-arm, prospective study will evaluate the safety, tolerability, and efficacy of CD22/CD19 dual-target chimeric antigen receptor T-cell (CAR-T) therapy as consolidation treatment in patients with high-risk B-cell acute lymphoblastic leukemia (B-ALL) who have achieved first remission after standard induction therapy and consolidation chemotherapy. Approximately 30 patients will be enrolled. Participants will undergo screening, cell collection for CAR-T manufacturing, lymphodepleting chemotherapy, and subsequent CAR-T cell infusion, followed by scheduled safety and efficacy follow-up. Safety assessments will include monitoring for cytokine release syndrome (CRS), neurotoxicity, hematologic toxicity, organ toxicity, infections, and other adverse events. Efficacy assessments will include event-free survival (EFS), overall survival (OS), progression-free survival (PFS), duration of response(DOR), relapse, and mortality. Exploratory analyses will assess CAR-T cell kinetic characteristics and clonal evolution after treatment.

Being tested
CD22/CD19 Dual-Target CAR-T Cells
Keywords
B-Cell Acute Lymphoblastic Leukemia, CAR-T Cell Therapy, Dual-Target CAR-T, CD19, CD22
Medical subject headings
Burkitt Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CD22/CD19 Dual-Target CAR-T CellsBiological

    Autologous CD22/CD19 dual-target chimeric antigen receptor T cells

Study groups in NCT07575971
Study groupRoleWhat they receive
CD22/CD19 Dual-Target CAR-T Cell TherapyExperimentalPatients will receive CD22/CD19 dual-target CAR-T cell therapy following lymphodepleting chemotherapy.
Receives: Biological: CD22/CD19 Dual-Target CAR-T Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1-year Event-Free Survival Rate (EFSR)

    The 1-year event-free survival rate after CD22/CD19 CAR-T cell therapy used as enhanced consolidation treatment in high-risk B-cell acute lymphoblastic leukemia.

    Measured: 1 years after CAR-T cell infusion

Secondary outcomes (6)

  1. Overall Survival (OS)

    From the date of CAR-T cell infusion until the date of death or last follow-up, assessed up to 1 years.

    Measured: Up to 1 years after CAR-T cell infusion

  2. Time to Progression (TTP)

    Time to progression (TTP) is defined as the time from CD22/CD19 chimeric antigen receptor T-cell (CAR-T) cell infusion to the date of first documented disease progression, as assessed by standard response criteria. Disease progression includes hematologic relapse, bone marrow relapse, or extramedullary disease progression.

    Measured: Up to 1 years after CAR-T cell infusion

  3. Disease-Free Survival (DFS)

    Disease-free survival (DFS) is defined as the time from CD22/CD19 chimeric antigen receptor T-cell (CAR-T) cell infusion to the first occurrence of disease relapse or death from any cause, whichever occurs first, in patients who achieve complete remission after treatment.

    Measured: Up to 1 years after CAR-T cell infusion

  4. Duration of Response (DOR)

    Duration of response (DOR) is defined as the time from the first documented achievement of complete remission or partial remission after CD22/CD19 chimeric antigen receptor T-cell (CAR-T) cell infusion to the date of disease relapse or progression, or death from any cause, whichever occurs first.

    Measured: Up to 1 years after CAR-T cell infusion

  5. Relapse Rate

    Relapse rate is defined as the proportion of patients who develop disease recurrence after achieving complete remission following CD22/CD19 CAR-T cell infusion, including hematologic, marrow, or extramedullary relapse.

    Measured: Up to 1 years after CAR-T cell infusion

  6. Incidence and Severity of Treatment-Emergent Adverse Events

    Include cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicities (anemia, leukopenia, neutropenia, thrombocytopenia), infections, electrolyte abnormalities, liver and renal function abnormalities, and other laboratory abnormalities.

    Measured: Up to 1 years after CAR-T cell infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2026
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07575971
Sponsor's protocol ID
S2025-1062-02
Status last verified
Jun 2026
First submitted
4 May 2026
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD22/CD19 Dual-Target CAR-T Cells in people with B-cell Acute Lymphoblastic Leukemia, run by Liping Dou 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 13 inclusion and 19 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 25 Jun 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.

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 Li-Ping Dou, Dr. (+8613681207138, lipingruirui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year Event-Free Survival Rate (EFSR) (time frame: 1 years after CAR-T cell infusion). 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 NCT07575971.

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 25 Jun 2026.

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