NCT04833504

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2018

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 16, 2025

Status Verified

January 1, 2021

Enrollment Period

5 years

First QC Date

December 14, 2020

Last Update Submit

July 13, 2025

Conditions

Diffuse Large B-cell LymphomaMantle Cell LymphomaTransformed Follicular LymphomaPrimary Mediastinal Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Evaluate the efficacy of CD19-IL7/CCL19 CAR-T

    Evaluate the efficacy of CD19-IL7/CCL19 CAR-T including duration of response, progression-free survival, overall surviva and objective response rate (CR + PR) .

    5 years

Secondary Outcomes (2)

  • Evaluate the persistence of CAR-T cells

    5 years

  • Evaluate the incidence of adverse events

    5 years

Interventions

CD19 CAR-T Expressing IL7 and CCL19BIOLOGICAL

A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

39 patients meet including and excluding criteria criteria

You may qualify if:

  • All patients who have received the CD19-IL7/CCL19 CAR-T therapy in the earlier enrolled clinical trail and met including and excluding criteria criteria (NCT0325847) Patients who have provided informed consent for the long term follow up study prior to their study participation .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hui Liu

Hangzhou, State..., 310000, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Wenbin Qian, Doctor

    Zhejiang University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2020

First Posted

April 6, 2021

Study Start

September 22, 2018

Primary Completion

September 22, 2023

Study Completion

October 1, 2024

Last Updated

July 16, 2025

Record last verified: 2021-01

Locations

CN(1)