Treatment with Inaticabtagene Autoleucel for Adult Leukemia Patients
Official title: 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
Run by Juventas Cell Therapy Ltd. · NCT06450067 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Juventas Cell Therapy Ltd. Industry-sponsored |
| Locations | 10 sites (Beijing, Beijing Municipality and 9 other locations) |
| Status | Recruiting |
| Started | June 5, 2024 |
| Main results expected | June 5, 2026 |
| Study ends | June 5, 2029 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT06450067 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promising results with similar CAR T-cell therapies, indicating potential for success in this approach.
Who can join: the full rules
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 it's running
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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
Show 4 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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CD19 and CD22 in vivo CAR-T therapy for relapsed/refractory B-ALL
This study tests a one-of-a-kind in vivo CAR-T treatment that targets CD19 first and then CD22 in adults with relapsed or refractory B-ALL to see if it is safe and possibly effective.
-
GI001 CAR-T for relapsed or refractory B-cell NHL and B-ALL
This treatment study tests GI001, an in vivo CAR-T therapy, to see if it is safe and helpful for adults with relapsed or refractory B-cell NHL or B-ALL.
-
Umbilical Cord Blood CAR-T Cells Targeting CD19 and CD22 for relapsed/refractory B-ALL
This phase 1 study tests whether dual-target cord blood-derived CAR-T cells against CD19 and CD22 are safe and tolerable in adults with relapsed or refractory B-cell ALL.
-
Dual-target CD22/CD19 CAR-T consolidation after first remission in high-risk B-ALL
This test will try a dual-target CD22/CD19 CAR-T cell treatment as consolidation for patients with high-risk B-cell acute lymphoblastic leukemia who are in their first remission.
-
CD22/CD19 CAR-T consolidation for adults with standard-risk B-ALL
This study will try dual-target CD22/CD19 CAR-T cell therapy as a consolidation treatment for adults with standard-risk B-cell acute lymphoblastic leukemia who are in first remission.
-
MK-1045 versus blinatumomab for relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia
This trial will test whether MK-1045 helps people with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia more than the standard immunotherapy blinatumomab.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.