Trials / Completed
CompletedNCT04833504
Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 39 (actual)
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs).
Detailed description
Patients are enrolled following completion from the early clinical study of CD19-7X19 CAR-T treatment ( NCT03258047) and will be followed for 5 years post treatment from the last treatment. They will be monitored for safety and efficacy with the primary treatment protocols for the protocol defined duration. This long-term following up study allow an interim analysis to evaluate the outcomes of the study when it arrives in 2 years Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies.
Conditions
- Diffuse Large B-cell Lymphoma
- Mantle Cell Lymphoma
- Transformed Follicular Lymphoma
- Primary Mediastinal Large B-cell Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD19 CAR-T Expressing IL7 and CCL19 | A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19 |
Timeline
- Start date
- 2018-09-22
- Primary completion
- 2023-09-22
- Completion
- 2024-10-01
- First posted
- 2021-04-06
- Last updated
- 2025-07-16
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04833504. Inclusion in this directory is not an endorsement.