CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory Large B-cell Lymphoma
This phase 2 study aims to evaluate the best overall response rate, which includes both complete and partial responses, in patients with relapsed or refractory large B-cell lymphoma, 3 months after receiving CD19/CD22 Bispecific CAR-T Cell Therapy.
CD19/CD22 bispecific CAR-T cells
Treatment Study
Summary
Study start date: February 1, 2022
Actual date on which the first participant was enrolled.Large B cell lymphoma is a common type of non-Hodgkin lymphoma, a cancer that starts in certain cells of the immune system. While many patients respond well to initial treatment, some experience a return or worsening of the disease, known as relapsed or refractory Large B cell lymphoma. Current treatments for this condition have limited effectiveness, highlighting the need for new approaches. One such approach is CAR-T cell therapy, which involves modifying the patient's own immune cells to better recognize and fight cancer cells. This study focuses on a specific type of CAR-T cell therapy that targets two proteins, CD19 and CD22, found on the surface of lymphoma cells. By targeting both proteins, this therapy aims to provide a more comprehensive treatment for patients with relapsed or refractory Large B cell lymphoma. In this phase 2 clinical trial, participants will receive the CD19/CD22 bispecific CAR-T cell therapy. The main goal is to evaluate the therapy's effectiveness, measured by the best overall response rate three months after the infusion of the CAR-T cells. This response rate includes both complete responses, where all signs of cancer disappear, and partial responses, where the cancer shrinks but does not completely disappear. The study also aims to assess the safety of this treatment.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 14 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Beijing Tongren Hospital, Capital Medical University
Beijing, ChinaOpen Beijing Tongren Hospital, Capital Medical University in Google Maps