Treatment with Inaticabtagene Autoleucel for Adult Leukemia Patients
To Observe and Evaluate the Efficacy and Safety of Inaticabtagene Autoleucel Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia in Adults in the Real World
This study is testing a new treatment called Inaticabtagene Autoleucel to see if it helps adults with relapsed or hard-to-treat B-cell acute lymphoblastic leukemia feel better and stay safe during their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Juventas Cell Therapy Ltd. Industry-sponsored |
| Locations | 10 sites (Beijing, Beijing Municipality and 9 other locations) |
| Trial ID | NCT06450067 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the efficacy and safety of Inaticabtagene Autoleucel Injection in adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. It involves a multicenter approach across various hospitals in China, focusing on real-world outcomes following treatment. The study includes a screening period for leukapheresis, a treatment period, and a follow-up period lasting up to two years to monitor patient responses and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia.
Not a fit: Patients who are not diagnosed with B-cell acute lymphoblastic leukemia or those who are not eligible for the treatment will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat leukemia.
How similar studies have performed: Other studies have shown promising results with similar CAR T-cell therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Autoleucel injection 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 from their legal guardian Exclusion Criteria: None
Where this trial is running
Beijing, Beijing Municipality and 9 other locations
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
- Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
- Qilu Hospital of Shandong university — Jinan, Shandong, China (Recruiting)
- Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)
- West China School of Medicine/West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: Jianxiang Wang, Dr. — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Qinghan Wang, master
- Email: 352074861@qq.com
- Phone: 86-13439319658
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.