B-cell Tumors
Conditions
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.
Interventions
Inaticabtagene autoleucel Injection
Sponsors
Juventas Cell Therapy Ltd.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYinling Wu
Outcome results
None listed