Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia

Last updated: September 18, 2024
Sponsor: Juventas Cell Therapy Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Lymphocytic Leukemia, Acute

Treatment

N/A

Clinical Study ID

NCT06450067
HY001402
  • Ages > 18
  • All Genders

Study Summary

This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years;

  2. Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;

  3. Patients deemed eligible for receiving commercial Inaticabtagene Autoleucelinjection treatment as determined by the investigator;

  4. Patients voluntarily participate in this study and sign an informed consent form.For patients lacking full legal capacity, informed consent must be obtained fromtheir legal guardian

Exclusion

Exclusion Criteria:

None

Study Design

Total Participants: 200
Study Start date:
June 05, 2024
Estimated Completion Date:
June 05, 2029

Study Description

The study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in the treatment of Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu
    China

    Active - Recruiting

  • Qilu Hospital of Shandong university

    Jinan, Shandong
    China

    Active - Recruiting

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai
    China

    Active - Recruiting

  • West China School of Medicine/West China Hospital of Sichuan University

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

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