This investigator-initiated, prospective, single-arm, open-label, single-center phase II study aims to evaluate the long-term survival benefit and safety of a commercial CD19 CAR-T product in newly diagnosed Philadelphia chromosome-positive or negative (Ph-positive or Ph-negative) B-cell ALL patients who achieve CR1 after induction chemotherapy. A total of 20 patients will be enrolled in the study. The primary endpoints include disease-free survival (DFS) and overall survival (OS) rates after a median follow-up of 2 years, minimal residual disease (MRD) negativity rate, and the proportion of patients undergoing subsequent hematopoietic stem cell transplantation (HSCT). The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after infusion will also be recorded.
Age ≥14 years and ≤70 years at screening, with no restrictions on gender.
ECOG performance status of 0 to 1.
Newly diagnosed B-ALL within 12 months and achieving CR1 after standard induction chemotherapy. This includes B-ALL patients with <5% bone marrow blasts, no blasts in peripheral blood, and no extramedullary leukemia. Diagnosis and chemotherapy regimen follow the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 Edition).
At the time of B-ALL diagnosis, leukemia cells in bone marrow or peripheral blood confirmed as CD19-positive via flow cytometry.
Diagnosis of Burkitt lymphoma/leukemia, heterozygous or double-hit leukemia, or chronic myeloid leukemia in blast crisis.
Presence of ≥5% blasts in the bone marrow or peripheral blood, or evidence of extramedullary leukemia before screening or preconditioning.
Prior treatment with CAR-T cell therapy or hematopoietic stem cell transplantation (HSCT) before screening or preconditioning.
Genetic syndromes associated with bone marrow failure, including Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known bone marrow failure syndromes.
Single group
Biological: single dose of Inaticabtagene autoleucel
Biological/VaccineInaticabtagene autoleucel will be transfusioned intravenously at the recommended dose of 0.5×10\^8 (ranging 0.2-0.6×10\^8) viable CAR-T cells.
2-year DFS rate (2yDFSR)
The proportion of patients who remain free from bone marrow disease relapse or death from any cause, assessed after a median follow-up of 2 years
2-year OS rate (2yDFSR)
The proportion of patients who remain alive after a median follow-up of 2 years
DFS
The time from Inati-cel infusion to morphological relapse of B-ALL in the bone marrow, or death from any cause (whichever occurs first).
OS
The time from Inati-cel infusion to death from any cause
Proportion of patient underwent subsequent hematopoieticstem cell transplantation
Proportion of patient underwent subsequent hematopoieticstem cell transplantation
MRD negativity rate
the proportion of patients achieved undetectable levels of minimal residual disease at Day 28、Month 2，3，6 by flow cytometry and at Day 28 by NGS
Maximum observed concentration(Cmax)
Time of Cmax (Tmax)
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