Long-term follow-up for people treated with inaticabtagene autoleucel
Official title: A Long Term Follow-up Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
Run by Juventas Cell Therapy Ltd. · NCT06461351 · Data updated 2026-11-12
This program will follow people who received inaticabtagene autoleucel to see if annual monitoring finds delayed side effects up to 15 years after their infusion.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Juventas Cell Therapy Ltd. Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | March 30, 2024 |
| Main results expected | May 30, 2039 |
| Study ends | March 30, 2040 |
| Registry record updated | August 7, 2025 |
| Trial ID | NCT06461351 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People who have already received at least one infusion of inaticabtagene autoleucel (from a clinical trial or commercial use), can provide informed consent, and can attend annual follow-up visits are ideal candidates.
✕Probably not a fit
Individuals who have not received inaticabtagene autoleucel, cannot provide consent, or are unable to attend yearly follow-up visits are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational program enrolls patients who previously received at least one infusion of inaticabtagene autoleucel, including those from prior clinical trials and commercial use. Participants re-consent and are followed once a year for up to 15 years after infusion to collect safety data, medical history, disease status, and any late adverse events. No new treatments are assigned; data are collected during routine clinic visits or scheduled follow-up assessments. The collected information is intended to characterize long-term safety after the product's commercialization.
Why it matters
Potential benefit: If successful, this long-term follow-up could reveal delayed adverse effects and help improve safety guidance and monitoring for future patients treated with inaticabtagene autoleucel.
How similar studies have gone: Other long-term follow-up programs for CAR-T therapies have successfully identified late effects such as prolonged cytopenias, hypogammaglobulinemia, and rare secondary malignancies, so this approach is an established method for monitoring safety.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Principal investigator: Jianxiang Wang, Dr. — Institute of Hematology & Blood Diseases Hospital, Tianjin, China
- Study coordinator: Yinling Wu
- Email: wuyinling@juventas.cn
- Phone: +86 13161292425
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.