Long-term follow-up for people treated with inaticabtagene autoleucel
A Long Term Follow-up Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Juventas Cell Therapy Ltd. Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06461351 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tianjin, Tianjin Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.