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

Active, not recruiting

• Conditions: B-cell Tumors

• Registration Number: NCT06461351
• Lead Sponsor: Juventas Cell Therapy Ltd.

Brief Summary

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.

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 Timeline

• Study Start: 2024-03-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-17
• Last Update Posted: 2024-06-17
• Primary Completion: 2039-05-30
• Study Completion: 2040-03-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Hematology & Blood Diseases Hospital; 🇨🇳 Tianjin, Tianjin, China