Unicar-Therapy's Breakthrough IL-6-Silenced CAR-T Therapy ssCART-19 Showcased at ESMO 2024 for Relapsed/Refractory B-ALL

Sep 10, 2024 17:36 CST Updated 17:36

Unicar-Therapy

Developer of Immune Cell and Gene Therapy Products

▎WuXi AppTec Content Team Report

The 2024 European Society for Medical Oncology (ESMO) Annual Meeting will be held in Barcelona, Spain, from September 13 to 17 local time. Currently, the ESMO conference official website has disclosed the abstract results selected for the Mini Oral presentations.Conducted by Unicar-TherapyssCART-19 Treatment for Refractory/Relapsed Acute Lymphoblastic Leukemia (Including Central Nervous System Leukemia)The latest clinical research progress has been successfully selected.

ssCART-19 is aAutologous T-cell Injection Engineered to Target CD19 with IL-6 Silencing FunctionIn May this year, the product's treatment of refractory/recurrent acute lymphoblastic leukemia has been included by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration.Breakthrough Therapy Drug。

According to the abstract introduction disclosed on the ESMO Congress official website, although CAR-T therapy has shown better efficacy in the treatment of hematologic malignancies in recent years, severe cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are still limiting its widespread application, especially in patients with acute lymphoblastic leukemia. Therefore, SHANGHAI UNICAR-THERAPY BIOMED-PHAMACEUTICAL TECHNOLOGY CO., LTD developed an autologous CD19-specific CAR-T cell product, ssCART-19.It can innovatively combine shRNA technology to silence the IL-6 gene, reduce the overall intensity of cytokine release, thereby decreasing the incidence of severe CRS/ICANS, and ultimately improve the clinical safety of CAR-T therapy.。

The oral report selected for this ESMO conference is ssCART-19 in Chinese adult R/R B-cellAcute Lymphoblastic Leukemia (ALL)A single-arm, open-label phase 1 study conducted in patients. All patients received a lymphodepletion regimen prior to ssCART-19 infusion. The primary endpoint was safety, and the secondary endpoint was efficacy.

In the study, ssCART-19 at 1×10⁶/kg、5×10⁶/kg and 10×10⁶/kg at three dose levels (DL). As of the data cutoff date on October 31, 2023 (median follow-up of 19.6 months), 17 patients received ssCART-19 treatment, and in 10 patients (58.8%), the cell count exceeded 50%.Safety data show,The most common AEs were lymphopenia (94.2%), transient neutropenia (88.2%), leukopenia (88.2%), anemia (70.6%), and thrombocytopenia (58.8%).Of the 17 patients, 13 (76.5%) developed CRS.No CRS of grade 4 or higher occurred.。One case (10.0%) of Grade 3 CRS occurred in the DL1 group.It is worth noting that,No patients developed ICANS,No deaths due to CRS or ICANS were reported.。

Efficacy data showed that, in evaluable patients (n=16),ORR within 3 months reached 87.5%`, Complete Response (CR) Rate`Is 62.5%,Complete Remission with Incomplete Hematologic Recovery (CRi) RateIs 25.0%。The 6-month median duration of response (DOR) rates for DL1, DL2, and DL3 were 100.0%, 80.0%, and 0.0%, respectively.Among them, 7 patients had sustained relief for more than 6 months. In addition,Patients with grade 2 central nervous system infiltration before ssCART-19 infusion did not develop ICANS and continued to experience remission after ssCART-19 treatment.。

Researchers believe that ssCART-19 has achieved a high remission rate in adult R/R B-cell ALL patients, and it can significantly improve the safety of CAR-T therapy, especially in patients with central nervous system infiltration.

References:

[1]ESMO Conference Official Website. fromhttps://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/31

[2] UNICAR-THERAPY's Innovative IL-6 Silencing Empowered CAR-T Product Latest Clinical Progress Presented at 2024 ESMO. Retrieved Sep 10， 2024, from https://mp.weixin.qq.com/s/vgn1h7kyI5Zs22bRfQLs2w

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