The purpose of this study is to deliver dual-targeting CAR-T cell therapy (CART 2219.1) as a salvage treatment to patients with relapsed/refractory B-lineage leukaemia in place of stem cell transplant or irradiation.

开始日期2022-07-18

申办/合作机构

KK Women's & Children's Hospital Pte Ltd.

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100 项与 Dual Anti-CD22/CD19 Chimeric Antigen Receptor-directed T Cells(KK Women's & Children's Hospital Pte Ltd.) 相关的临床结果

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100 项与 Dual Anti-CD22/CD19 Chimeric Antigen Receptor-directed T Cells(KK Women's & Children's Hospital Pte Ltd.) 相关的转化医学

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100 项与 Dual Anti-CD22/CD19 Chimeric Antigen Receptor-directed T Cells(KK Women's & Children's Hospital Pte Ltd.) 相关的专利（医药）

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项与 Dual Anti-CD22/CD19 Chimeric Antigen Receptor-directed T Cells(KK Women's & Children's Hospital Pte Ltd.) 相关的文献（医药）

2021-06-01·Clinical Lymphoma Myeloma and Leukemia4区 · 医学

Successful Treatment of TCF3-HLF–positive Childhood B-ALL with Chimeric Antigen Receptor T-Cell Therapy

4区 · 医学

Article

作者: Luo, Chengjuan ; Chen, Jing ; Ding, Lixia ; Wan, Xinyu ; Tang, Yanjing ; Liu, Rui ; Yang, Fan ; Wang, Xiang ; Li, Benshang ; Wang, Tianyi ; Yang, Xiaomin ; Ma, Yani ; Liang, Huanhuan ; Lu, Jun ; Shi, Wenhua

BACKGROUNDTCF3-HLF positive leukemia represents a rare subtype of B-cell acute lymphoblastic leukemia (B-ALL), characterized by a high treatment failure rate despite intensive treatment and hematopoietic stem cell transplantation (HSCT).PATIENTS AND METHODSFour consecutive children with TCF-HLF3-positive B-ALL who were refractory or relapsed with initial chemotherapy were treated with CD19-specific or combined CD19-and CD22-specific chimeric antigen receptor T-cell therapy (19/22 CAR-T) after conditioning regimen with fludarabine and cyclophosphamide. Clinical features, treatment responses, toxicity, and outcomes were analyzed retrospectively.RESULTSFour patients received 18.0, 6.0, 5.0, and 7.4 × 10⁶ CAR-T cells per kilogram and developed grade I, III, II, and III cytokine release syndrome, respectively. They all achieved minimal residual disease-negative complete remission (CR). Two of them (patients 1 and 3) underwent haploid HSCT afterward. Patient 1 relapsed after 7.2 months of transplantation and received donor-derived 19/22 CAR-T cell infusion. He had CR2 after he experienced grade II cytokine release syndrome of the second CAR-T and underwent umbilical cord blood transplantation. Unfortunately, this child died of severe lung graft versus host disease 8.4 months after the second transplantation. Patients 2 and 4 experienced reversible neurotoxicity and had a persistent clinical response to CAR-T cells for 13.8 and 6.8 months, respectively, without HSCT. Patient 3 is in continuous CR for 10.6 months until now.CONCLUSIONCAR-T cells can effectively treat relapsed/refractory TCF3-HLF-positive childhood B-ALL with acceptable toxicity, which could be a new treatment option for this subtype compared with chemotherapy or HSCT.

2021-03-01·Bone Marrow Transplantation3区 · 医学

Taming the beast: CRS and ICANS after CAR T-cell therapy for ALL

3区 · 医学

Review

作者: Gauthier, Jordan ; Sheth, Vipul S

Treatment with CD19 or CD22-targeted chimeric antigen receptor-engineered T (CD19/CD22 CAR-T) cells achieve complete responses in 60-90% of adults and children with refractory or relapsed (R/R) acute lymphoblastic leukemia (ALL). This led to the approval of tisagenlecleucel (Kymriah) by the FDA and several European regulatory agencies in ALL patients up to 25 years of age. Although CAR T-cell therapy is likely to transform the ALL therapeutic landscape, its development and wide dissemination have been impacted by the occurrence of significant toxicities; namely, cytokine release syndrome (CRS) and Immune effector cell-Associated Neurotoxicity Syndrome (ICANS) have been reported at higher rates in ALL patients compared to other B cell malignancies, particularly in the adult population. Here, we review recent data suggesting a significant proportion of ALL patients are at risk of developing severe, sometimes life-threatening, CRS, and ICANS after CD19 and CD22 CAR T-cell therapy. After describing the key clinical and laboratory features of severe CRS and ICANS, we explore the disease and treatment-related factors that may predict the severity of these toxicities. Last, we review strategies under investigation in the prophylactic and therapeutic settings to improve the safety of CAR T-cells for ALL.

100 项与 Dual Anti-CD22/CD19 Chimeric Antigen Receptor-directed T Cells(KK Women's & Children's Hospital Pte Ltd.) 相关的药物交易

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