Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhiMar 25, 2024

Safety and effectiveness of engineered immune cell therapy followed by donor stem cell transplant in 21 patients with a high-risk type of acute lymphoblastic leukemia

Updated Feb 7, 2026

Abstract

Of the 21 patients treated with CAR-T therapy followed by allogeneic stem cell transplantation, 95.2% achieved complete remission within 28 days.

The median age of patients at the time of CAR-T therapy was 22 years.
Prior to CAR-T therapy, 12 patients had experienced a hematologic relapse, with varying minimal residual disease statuses.
Nineteen patients developed grade 0-2 cytokine release syndrome, while two experienced grade 3, all of which resolved with treatment.
Five patients experienced relapse after CAR-T therapy, with four having hematologic relapse and one a molecular relapse.
Three-year overall survival rates were 83.3% for the ABL1 group and 66.6% for the JAK-STAT group, with no significant difference between them.
Three-year relapse-free survival rates were 50.0% and 55.6% for the ABL1 and JAK-STAT groups, respectively.

Simplified

To evaluate the efficacy and safety of chimeric antigen receptor T-cell (CAR-T) therapy followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with Ph-like acute lymphoblastic leukemia (Ph-ALL) .Patients with Ph-ALL who underwent CAR-T therapy followed by allo-HSCT from March 2018 to August 2023 at the First Affiliated Hospital of Soochow University were included, and their clinical data were retrospectively analyzed.Of the 21 patients, 14 were male and 7 were female. The median age at the time of CAR-T therapy was 22 (6-50) years. Seven patients had ABL1-like rearrangements, and 14 had JAK-STAT rearrangements. Prior to CAR-T therapy, 12 patients experienced hematologic relapse; 7 were multiparameter flow cytometry minimal residual disease (MFC-MRD) -positive and 2 were MFC-MRD-negative. CAR-T cells were derived from patients' autologous lymphocytes. Nine patients were treated with CD19 CAR-T cells, and 12 were treated with CD19/CD22 CAR-T cells. After assessment on day 28 after CAR-T therapy, 95.2% of the patients achieved complete remission, with an MRD-negative remission rate of 75%. Nineteen patients developed grade 0-2 cytokine release syndrome (CRS) and 2 patients suffered grade 3 CRS, all cases of which resolved after treatment. All patients underwent allo-HSCT after CAR-T therapy. The median time from CAR-T therapy to allo-HSCT was 63 (38-114) days. Five patients experienced relapse after CAR-T therapy, including four with hematologic relapse and one with molecular relapse. The 3-year overall survival (OS) rates in the ABL1 and JAK-STAT groups were (83.3±15.2) % and (66.6±17.2) %, respectively (=0.68) . The 3-year relapse-free survival (RFS) rates were (50.0±20.4) % and (55.6±15.4) % in the ABL1 and JAK-STAT groups, respectively. There was no significant difference in 3-year OS or RFS between the two groups.CAR-T therapy followed by allo-HSCT leads to rapid remission in most patients with Ph-ALL and prolongs leukemia-free survival. Objective: Methods: Results: Conclusions: P

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