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

Conditions

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

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.

Wenbin Qian, Aiqi Zhao, Hui Liu, Wen Lei, Minghuan Zhang et al. (7 authors)

Blood2025-11-03

10.1182/blood-2025-3707

Long-Term Efficacy and Safety of CD19-Specific CAR-T Cells Armed with IL-7 and CCL19 in Patients with Relapsed or Refractory Large B-Cell Lymphoma: A Multi-Center Prospective Study

Wenbin Qian, Hui Liu, Wen Lei, Linqin Wang, Panpan Chen

Blood2024-11-051 citations

10.1182/blood-2024-205376

Safety and feasibility of anti-CD19 CAR T cells expressing inducible IL-7 and CCL19 in patients with relapsed or refractory large B-cell lymphoma.

Lei W, Zhao A, Liu H, Yang C, Wei C, Guo S, Chen Z, Guo Q, Li L, Zhao M, Wu G, Ouyang G, Liu M, Zhang J, Gao J, Qian W.

2024-01-0918 citations

10.1038/s41421-023-00625-0

Safety and Feasibility of Anti-CD19 CAR-T Expressing IL-7 and CCL19 in Patients with Relapsed or Refractory Large B-Cell Lymphoma

Wen Lei, Zhao Ai, Hui Liu, Chunmei Yang, Wei Cheng et al. (14 authors)

Blood2022-11-155 citations

10.1182/blood-2022-156635

Interventions

BIOLOGICALCD19 CAR-T Expressing IL7 and CCL19

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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;

Countries

China

Outcome results

None listed