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

Juventas Cell Therapy

Status: Enrolling

Conditions: B-cell Tumors

Treatments: Other: Inaticabtagene autoleucel Injection

Study type: Observational

Funder types: Industry

Identifiers

NCT06461351

HY001401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.