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.
• 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.
• 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.