Combination of Inaticabtagene Autoleucel With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.

Clinical Study of Inaticabtagene Autoleucel Combined With Autologous Hematopoietic Stem Cell Transplantation for Adolescents or Adults With MRD-Positive B-Cell Acute Lymphoblastic Leukemia in Initial Complete Remission.

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.

Evaluate the safety and efficacy of Inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with MRD-positive initial complete remission in B-cell acute lymphoblastic leukemia.

Inclusion Criteria:

• ECOG score of 0 to 1
• Newly diagnosed Ph-negative B-ALL within 6 months, achieving CR1 after standard induction chemotherapy, undergoing at least one consolidation therapy, and patients with bone marrow MRD ≥ 0.01% detected by routine flow cytometry.
• Or newly diagnosed Ph-positive B-ALL within 6 months, achieving CR1 after guideline-recommended induction chemotherapy (or use of TKI), undergoing at least one consolidation therapy, and patients with BCR-ABL1 > 0% detected by routine q-PCR technology.
• No significant organ dysfunction
• Willing and meet the conditions for autologous hematopoietic stem cell transplantation

Exclusion Criteria:

• Burkitt lymphoma/leukemia, heterozygous or double-expressor leukemia, or chronic myeloid leukemia in blast phase.
• Before screening or pre-treatment, bone marrow or peripheral blood with blasts ≥ 5%; or extramedullary leukemia.
• Individuals who have received CAR-T cell therapy before screening or pre-treatment; or patients who have undergone hematopoietic stem cell transplantation.
• Patients with associated genetic syndromes related to bone marrow failure, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndromes.