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

NCT06461351 | Recruiting

• 1 other identifier: HY001401
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

B-cell Tumors

Outcome Measures

Primary Outcomes (1)

• Replication-competent lentivirus，RCL

  Real time quantitative polymerase chain reaction was used for detection, QPCR method.

  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

  once a year from date of Inaticabtagene Autoleucel Injection treatment until date of death from any cause, assessed up to 15 years.

Interventions

Inaticabtagene autoleucel Injection OTHER

Inaticabtagene autoleucel Injection

Also known as: CNCT19

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Registered clinical trial patients with different indications and post market commercialized patients who have received treatment with Inaticabtagene Autoleucel Injection

You may qualify if:

• 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.

You may not qualify if:

• \- None.

Sponsors & Collaborators

• Juventas Cell Therapy Ltd.: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Study Officials

• Jianxiang Wang, Dr.

  Institute of Hematology & Blood Diseases Hospital, Tianjin, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yinling Wu

CONTACT

+86 13161292425; wuyinling@juventas.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 17, 2024
• Study Start: March 30, 2024
• Primary Completion (Estimated): May 30, 2039
• Study Completion (Estimated): March 30, 2040
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)