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

NCT ID: NCT06461351

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-30

Study Completion Date

2040-03-30

Brief Summary

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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

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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.

Conditions

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B-cell Tumors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Inaticabtagene autoleucel Injection

Inaticabtagene autoleucel Injection

Intervention Type OTHER

Other Intervention Names

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CNCT19

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Juventas Cell Therapy Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianxiang Wang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, Tianjin, China

Locations

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Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yinling Wu

Role: CONTACT

+86 13161292425

Facility Contacts

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Jianxiang Wang, Dr.

Role: primary

Other Identifiers

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HY001401

Identifier Type: -

Identifier Source: org_study_id

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