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NCT Number: NCT06461351

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

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.

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Key information

Conditions

B-cell Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location status: Recruiting

Location contact

Jianxiang Wang, Dr.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • None.

Treatment and study plan

Inaticabtagene autoleucel Injection

Other

Inaticabtagene autoleucel Injection

Other names: CNCT19

Primary outcomes

  1. 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

  1. Long-term Adverse Drug Reaction

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Yinling Wu

CONTACT

[email protected]

+86 13161292425

Sponsors and collaborators

Lead sponsor

Juventas Cell Therapy Ltd.

Industry

Registry information

Official study title

A Long Term Follow-up Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection

Important dates

Study start
2024
Primary completion
2039
Study completion
2040
First posted
Jun 17, 2024
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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