Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
ConditionB-cell Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJuventas Cell Therapy Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Registered clinical trial patients with different indications and post market commercialized patients who have received treatment with Inaticabtagene Autoleucel Injection
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Inaticabtagene autoleucel Injection
Other interventionInaticabtagene autoleucel Injection
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Replication-competent lentivirus，RCL
Real time quantitative polymerase chain reaction was used for detection, QPCR method.
Time frame
once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.Secondary outcomes
1
Long-term Adverse Drug Reaction
Individual adverse drug reactions related to Inaticabtagene Autoleucel Injection after marketing, mainly including secondary tumors, etc after marketing, mainly including secondary tumors, etc
Time frame
once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov