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

NCT ID: NCT06450067

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-05

Study Completion Date

2029-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

B-cell Acute Lymphoblastic Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia

Diagnosed relapsed or refractory B-cell acute lymphoblastic leukemia

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Juventas Cell Therapy Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jianxiang Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Aibin Liang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

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

Wuhan, Hubei, China

Site Status RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status RECRUITING

Qilu Hospital of Shandong university

Jinan, Shandong, China

Site Status RECRUITING

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

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

Chengdu, Sichuan, China

Site Status RECRUITING

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Qinghan Wang, master

Role: CONTACT

86-13439319658

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Meng Lv, Dr.

Role: primary

Hongmei Jing, Dr.

Role: primary

Yuhua Li, Dr.

Role: primary

Qingsong Yin, Dr.

Role: primary

Heng Mei, Dr.

Role: primary

Zhenyu Li, Dr.

Role: primary

Jun Peng, Dr.

Role: primary

Aibin Liang, Dr.

Role: primary

Ting Niu, d

Role: primary

Jianxiang Wang, Dr.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HY001402

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Blinatumomab Bridging Therapy for BALL
NCT04556084 TERMINATED PHASE2
BY002 IIT Study in R/R Acute Leukemia
NCT07270770 RECRUITING PHASE1