CClinicalTrials.gg
RecruitingNCT06461351Updated Aug 7, 2025

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

An observational study in B-cell Tumors, sponsored by Juventas Cell Therapy Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Juventas Cell Therapy Ltd. · Observational

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • B-cell Tumors
03

In context

Lead sponsor

Juventas Cell Therapy Ltd. is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

- None.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Interventions

  • OtherInaticabtagene autoleucel Injection

    Inaticabtagene autoleucel Injection

    Also known as: CNCT19

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What researchers measure

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.

07

Study locations

1 of 1 sites recruiting
  • Institute of Hematology & Blood Diseases Hospital
    Tianjin, Tianjin Municipality, China
    • Jianxiang Wang, Dr. · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06461351
Lead sponsor
Juventas Cell Therapy Ltd.
Responsible party
Sponsor
First posted
Jun 17, 2024
Start date
Mar 30, 2024
Primary completion
May 30, 2039 (estimated)
Completion
Mar 30, 2040 (estimated)
Last update
Aug 7, 2025

Study contacts

Yinling Wu
Contact
wuyinling@juventas.cn
+86 13161292425
Jianxiang Wang, Dr.
principal investigator · Institute of Hematology & Blood Diseases Hospital, Tianjin, China

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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