NCT06461351

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Juventas Cell Therapy Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• B-cell Tumors

Interventions

Type	Name	Description
OTHER	Inaticabtagene autoleucel Injection	Inaticabtagene autoleucel Injection

Timeline

• Start date: 2024-03-30
• Primary completion: 2039-05-30
• Completion: 2040-03-30
• First posted: 2024-06-17
• Last updated: 2025-08-07

Locations

1 site across 1 country: China