Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma

Completed

• Conditions: Primary Mediastinal Large B-cell Lymphoma; Diffuse Large B-cell Lymphoma; Transformed Follicular Lymphoma; Mantle Cell Lymphoma

• Registration Number: NCT04833504
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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).

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.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2019-10-01
• Study Completion: 2020-10-01
• Study First Submitted: 2020-12-14
• Status Verified: 2021-01
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-04
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• 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 .

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Exclusion Criteria

• There are no specific exclusion criteria for this study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the efficacy of CD19-IL7/CCL19 CAR-T	5 years	Evaluate the efficacy of CD19-IL7/CCL19 CAR-T including duration of response, progression-free survival, overall surviva and objective response rate (CR + PR) .

Secondary Outcome Measures

Name	Time	Method
Evaluate the persistence of CAR-T cells	5 years	Levels and persistence of CAR+ T cells in serum samples
Evaluate the incidence of adverse events	5 years	The incidence of CRS and CRES; Levels and persistence of cytokines in serum samples;Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death ;B- and T- lymphocyte count;

Trial Locations

Locations (1)

Hui Liu; 🇨🇳 Hangzhou, State..., China