A Long Term Follow-up Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- B-cell Tumors
- Sponsor
- Juventas Cell Therapy Ltd.
- Enrollment
- 1000
- Locations
- 1
- Primary Endpoint
- Replication-competent lentivirus，RCL
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Agree to sign an informed consent form for long-term follow-up studies.
- •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
- Not provided
Outcomes
Primary Outcomes
Replication-competent lentivirus，RCL
Time Frame: 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 Outcomes
- 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.)