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

B-cell Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06450067
• Other study ID #: HY001402
• Status: Not yet recruiting
• Start date: June 5, 2024
• Est. completion date: June 5, 2029

Study information

• Verified date: June 2024
• Source: Juventas Cell Therapy Ltd.
• Contact: Qinghan Wang, master
• Phone: 86-13439319658
• Email: 352074861[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 5, 2029
• Est. primary completion date: June 5, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Juventas Cell Therapy Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	OS is defined as the time from the start date of Inaticabtagene Autoleucel Injection infusion to the date of death due to any cause.	2 years