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

Mantle Cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833504
• Other study ID #: I20200011057
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 .

Exclusion Criteria:

• There are no specific exclusion criteria for this study.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Primary Mediastinal Large B-cell Lymphoma
• Transformed Follicular Lymphoma

Intervention

Biological:
• CD19 CAR-T Expressing IL7 and CCL19
A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19

Locations

Country	Name	City	State
China	Hui Liu	Hangzhou	State...

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evaluate the persistence of CAR-T cells	Levels and persistence of CAR+ T cells in serum samples	5 years
Secondary	Evaluate the incidence of adverse events	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;	5 years