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.
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).
Age between 18 and 85 years, regardless of sex.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Prior treatment with any CAR-T cell therapy or other genetically modified T-cell therapies.
Known history of HIV infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics.
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.
Single group
CD22/CD19 Dual-Target CAR-T Cells
Biological/VaccineAutologous CD22/CD19 dual-target chimeric antigen receptor T cells
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.
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.
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.
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.
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.
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Liping Dou
Lead sponsor
Chinese PLA General Hospital
Sponsor institution
