Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection

A Long Term Follow-up Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection

This clinical trial adopts an observational research method to conduct annual follow-up and monitoring of patients receiving treatment with Inaticabtagene Autoleucel Injection after its commercialization, in order to evaluate the delayed adverse events of Inaticabtagene Autoleucel Injection.

Study Overview

• Status: Recruiting
• Conditions: B-cell Tumors
• Intervention / Treatment: Other: Inaticabtagene autoleucel Injection

Detailed Description

Patients treated with Inaticabtagene Autoleucel Injection (including registered clinical trial patients with different indications of this product and commercialized patients after market launch), would be included in this program for a maximum of 15 years of long-term follow-up (LTFU), and an informed consent form must be signed again. The research period was 15 years after Inaticabtagene Autoleucel infusion. The patient was followed up once a year for 15 years.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Yinling Wu; Phone Number: +86 13161292425; Email: wuyinling@juventas.cn

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Institute of Hematology & Blood Diseases Hospital
      • Contact: Jianxiang Wang, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Registered clinical trial patients with different indications and post market commercialized patients who have received treatment with Inaticabtagene Autoleucel Injection

Description

Inclusion Criteria:

1. Agree to sign an informed consent form for long-term follow-up studies.
2. Registered clinical trial patients with different indications for this product who have received at least one infusion of Inaticabtagene Autoleucel Injection in the past, as well as post market commercialized patients.

Exclusion Criteria:

- None.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Replication-competent lentivirus，RCL	Real time quantitative polymerase chain reaction was used for detection, QPCR method.	once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term Adverse Drug Reaction	Individual adverse drug reactions related to Inaticabtagene Autoleucel Injection after marketing, mainly including secondary tumors, etc after marketing, mainly including secondary tumors, etc	once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.

Collaborators and Investigators

• Sponsor: Juventas Cell Therapy Ltd.
• Investigators: Principal Investigator: Jianxiang Wang, Dr., Institute of Hematology & Blood Diseases Hospital, Tianjin, China

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Estimated): May 30, 2039
• Study Completion (Estimated): March 30, 2040

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HY001401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No