Inaticabtagene autoleucel in adult relapsed or refractory B-cell acute lymphoblastic leukemia

Before November 2023, CD19 chimeric antigen receptor (CAR) T-cell therapies had not been approved in China for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), leaving a significant unmet need. In response, inaticabtagene autoleucel (Inati-cel), a novel CD19 CAR T-cell therapy with a distinct single-chain variable fragment (HI19α), was developed and showed promising efficacy in preliminary clinical research. We conducted a phase 2, single-arm, multicenter study of Inati-cel in adult CD19+ R/R B-ALL in China. The primary end point was the overall remission rate (ORR) at the end of month 3. Forty-eight patients who underwent Inati-cel infusion were evaluated for both efficacy and safety. Among them, 34 patients achieved and maintained remission beyond 3 months, with a 3-month ORR of 70.8% (95% confidence interval [CI], 55.9-83.1). The best ORR was 85.4%, with all responders reaching minimal residual disease negativity. With a median follow-up of 23.7 months, the median duration of remission was 20.7 months (95% CI, 6.4 to not reached), and the median overall survival was not reached (95% CI, 13.0 months to not reached). Additionally, grade ≥3 cytokine release syndrome and neurologic events occurred in 12.5% and 6.2% of patients, respectively. The 2-year follow-up data suggest that Inati-cel demonstrates encouraging and durable responses with manageable safety profiles in R/R B-ALL. Based on the data from this pivotal trial, Inati-cel was approved as the first CAR T-cell therapy for adult R/R B-ALL in China and underscores its potential therapeutic benefits for this patient population. This trial was registered at www.ClinicalTrials.gov as #NCT04684147.

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Publication Details

Journal
Blood Advances
Published
2024-12-03
DOI
https://doi.org/10.1182/bloodadvances.2024014182
Citations
10
Primary Topic
CAR-T cell therapy research
Type
article
Field-Weighted Citation Impact
2.83

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article

Inaticabtagene autoleucel in adult relapsed or refractory B-cell acute lymphoblastic leukemia

Qifa Liu, Aibin Liang, Yiping Deng, Jienan Ren et al.
10 citations
Blood Advances
CAR-T cell therapy research
2.83
article

Inaticabtagene autoleucel in adult relapsed or refractory B-cell acute lymphoblastic leukemia

Qifa Liu, Aibin Liang, Yiping Deng, Jienan Ren, Heng Mei, Hongsheng Zhou, Yi Feng, Ting Niu, Jianxiang Wang, Shuangyou Liu, Lulu Lv, Ying Wang, Kailin Xu, Wei Jin, Yan Zhou, Jie Jin, Xudong Wei, Dongmei Yan, Runxia Gu, Cheng Zhang, Yongping Song
article en
10 citations

Abstract

Before November 2023, CD19 chimeric antigen receptor (CAR) T-cell therapies had not been approved in China for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), leaving a significant unmet need. In response, inaticabtagene autoleucel (Inati-cel), a novel CD19 CAR T-cell therapy with a distinct single-chain variable fragment (HI19α), was developed and showed promising efficacy in preliminary clinical research. We conducted a phase 2, single-arm, multicenter study of Inati-cel in adult CD19+ R/R B-ALL in China. The primary end point was the overall remission rate (ORR) at the end of month 3. Forty-eight patients who underwent Inati-cel infusion were evaluated for both efficacy and safety. Among them, 34 patients achieved and maintained remission beyond 3 months, with a 3-month ORR of 70.8% (95% confidence interval [CI], 55.9-83.1). The best ORR was 85.4%, with all responders reaching minimal residual disease negativity. With a median follow-up of 23.7 months, the median duration of remission was 20.7 months (95% CI, 6.4 to not reached), and the median overall survival was not reached (95% CI, 13.0 months to not reached). Additionally, grade ≥3 cytokine release syndrome and neurologic events occurred in 12.5% and 6.2% of patients, respectively. The 2-year follow-up data suggest that Inati-cel demonstrates encouraging and durable responses with manageable safety profiles in R/R B-ALL. Based on the data from this pivotal trial, Inati-cel was approved as the first CAR T-cell therapy for adult R/R B-ALL in China and underscores its potential therapeutic benefits for this patient population. This trial was registered at www.ClinicalTrials.gov as #NCT04684147.

Blood AdvancesVol. 9(4)
Tongji University (CN), Beijing Tongren Hospital (CN), Union Hospital (HK), Army Medical University (CN), Xuzhou Medical College (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Sichuan University (CN), Zhengzhou University (CN), West China Hospital of Sichuan University (CN), Nanfang Hospital (CN), Affiliated Hospital of Xuzhou Medical College (CN), Xinqiao Hospital (CN), Beijing Hospital (CN), Wuhan Union Hospital (CN), Henan Cancer Hospital (CN), Institute of Hematology & Blood Diseases Hospital (CN), Shanghai Cell Therapy Research Institute (CN), First Affiliated Hospital of Zhengzhou University (CN), Tongji Hospital (CN), Union Hospital (CN), First Affiliated Hospital Zhejiang University (CN), Huazhong University of Science and Technology (CN), Southern Medical University (CN)
University of Texas MD Anderson Cancer Center
Good health and well-being
Openalex Percentile: Top 7%
CAR-T cell therapy research
2.83
DOIOpen Access PDFOpenAlex
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