An Open Label, Single-site, Dose-escalation Study Aiming to Evaluate the Efficacy and Safety of Anti-CD19 CAR-T Manufactured by OlyCAR Platform(OlyCAR-019) in the Treatment of Relapsed/ Refractory(r/r) B-Cell Malignancies

It is a single-center, open-labeled, single-arm, non-randomized, investigator-initiated trial aiming to evaluate the efficacy and safety of anti-CD19 CAR-T manufactured by OlyCAR platform (OlyCAR-019) for CD19+ refractory/relapsed B-Cell malignancies.

Start Date01 Jul 2023

Sponsor / Collaborator

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

100 Clinical Results associated with OlyCAR-019

100 Translational Medicine associated with OlyCAR-019

100 Patents (Medical) associated with OlyCAR-019

Literatures (Medical) associated with OlyCAR-019

01 Dec 2023·Hematological Oncology

Early granulocyte colony stimulating factor administration increases the risk of cytokine release syndrome in acute lymphoblastic leukemia patients receiving anti‐CD19 chimeric antigen receptor T‐cell therapy

Article

Author: Zhou, Lijuan ; Tu, Sanfang ; Han, Shi ; Cao, Manxiong ; Su, Yongzhong ; Li, Yuhua ; Qiu, Yingqi

AbstractCytokine release syndrome (CRS), immune effector cell‐associated neurotoxicity syndrome (ICANS) and neutropenia are common toxicities associated with chimeric antigen receptor T (CAR‐T) cell therapy. The role of granulocyte colony stimulating factor (G‐CSF) in CAR‐T‐cell‐treated patients remains unclear. To explore the efficacy and safety of early G‐CSF administration in patients with relapsed/refractory B‐cell acute lymphoblastic leukemia (R/R B‐ALL) who were receiving autologous anti‐CD19 CAR‐T cells, we retrospectively collected and summarized clinical data to compare patients receiving G‐CSF within 14 days (early G‐CSF group) to patients receiving later or no G‐CSF (control group) after their CART infusion. The results showed that there was no significant difference in the incidence and duration of neutropenia between the early G‐CSF group and the control group (77% vs. 63%, p = 0.65; 8 vs. 4 days, p = 0.37, respectively). However, the incidence and duration of CRS were significantly higher in the early G‐CSF group than in the control group (81% vs. 38%, p = 0.03; 3 vs. 0 days, p = 0.004, respectively). Moreover, early G‐CSF application had no significant effect on the expansion and efficacy of CAR‐T cells. In conclusion, our study suggested that early G‐CSF administration did not reduce the incidence and duration of neutropenia but rather increased the incidence and duration of CRS.

13 May 2023·Cancers

Novel Drugs and Radiotherapy in Relapsed Lymphomas: Abscopal Response and Beyond.

Review

Author: De Sanctis, Vitaliana ; Pulsoni, Alessandro ; Iamundo De Cumis, Ilenia ; Perrone, Salvatore ; Strati, Paolo ; Lopedote, Paolo

Combined modality has represented a mainstay of treatment across many lymphoma histologies, given their sensitivity to both multi-agent chemotherapy and intermediate-dose radiotherapy. More recently, several new agents, including immunotherapies, have reshaped the therapeutic panorama of some lymphomas. In parallel, radiotherapy techniques have witnessed substantial improvement, accompanied by a growing understanding that radiation itself comes with an immune-mediated effect. Six decades after a metastatic lesion regression outside the irradiated field was first described, there is increasing evidence that a combination of radiotherapy and immunotherapy could boost an abscopal effect. This review focuses on the mechanisms underlying this interaction in the setting of lymphomas, and on the results of pivotal prospective studies. Furthermore, the available evidence on the concomitant use of radiotherapy and small molecules (i.e., lenalidomide, venetoclax, and ibrutinib), as well as brentuximab vedotin, and chimeric antigen receptor (CAR) T-cell therapy, is summarized. Currently, combining radiotherapy with new agents in patients who are affected by lymphomas appears feasible, particularly as a bridge to anti-CD19 autologous CAR T-cell infusion. However, more studies are required to assess these combinations, and preliminary data suggest only a synergistic rather than a curative effect.

01 Nov 2022·Leukemia

Characteristics of anti-CLL1 based CAR-T therapy for children with relapsed or refractory acute myeloid leukemia: the multi-center efficacy and safety interim analysis

Article

Author: Hu, Zhengbin ; He, Yingyi ; Li, Guangchao ; Zhou, Zhao ; Zheng, Yongwei ; Bu, Chaoke ; Ding, Wen ; Luo, Min ; Zhang, Hui ; Li, Chunfu ; Peng, Zhiyong ; Pei, Kunlin

C-type lectin-like molecule-1 (CLL1) is preferentially expressed on acute myeloid leukemia (AML) stem cells and AML blasts, which can be considered as AML-associated antigen. Anti-CLL1-based CAR-T cells exhibited effective tumor-killing capacity in vitro and in AML-bearing mouse model. In this report, eight children with relapsed or refractory AML (R/R-AML) were recruited for a phase 1/2 clinical trial of autologous anti-CLL1 CAR-T cell immunotherapy. The objectives of this clinical trial were to evaluate the safety and the preliminary efficacy of anti-CLL1 CAR-T cell treatment. Patients received one dose of autologous anti-CLL1 CAR-T cells after lymphodepletion conditioning. After CAR-T treatment, patients developed grade 1-2 cytokine release syndrome (CRS) but without any lethal events. 4 out of 8 patients achieved morphologic leukemia-free state (MLFS) and minimal residual disease (MRD) negativity, 1 patient with MLFS and MRD positivity, 1 patient achieved complete remission with incomplete hematologic recovery (CRi) but MRD positivity, 1 patient with partial remission (PR), and 1 patient remained at stable disease (SD) status but had CLL1-positive AML blast clearance. These results suggested that anti-CLL1-based CAR-T cell immunotherapy can be considered as a well-tolerated and effective option for treating children with R/R-AML.

100 Deals associated with OlyCAR-019

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
B-Cell Leukemia	Phase 2	CN	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	01 Jul 2023
B-Cell Lymphoma	Phase 2	CN	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	01 Jul 2023
B-Cell Malignant Neoplasm	Discovery	CN	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	01 Apr 2020
Pre B-cell acute lymphoblastic leukemia	Discovery	CN	920th Hospital of Joint Logistics Support Force of People's Liberation Army of China	01 Apr 2020

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