Recruiting

CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory Large B-cell Lymphoma

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

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.

What is being tested

CD19/CD22 bispecific CAR-T cells

Drug
Who is being recruted

From 14 to 85 Years
+20 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2022
See protocol details

Summary

Principal SponsorBeijing Tongren Hospital
Study ContactLiang Wang, M.D.More contacts
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleCD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma: A Prospective, Single-Arm, Single-Center, Phase 2 Trial
NCT07461831
Principal SponsorBeijing Tongren Hospital
Study ContactLiang Wang, M.D.More contacts
Last updated: March 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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

14 inclusion criteria required to participate
ECOG-PS score=0-2

No serious allergic constitution

14 years to 85 years, expected survival > 3 months

CD19 positive with or without CD22 positive Large B-cell lymphoma

Show More Criteria

6 exclusion criteria prevent from participating
Pregnant or lactating women (female participants of reproductive potential must have a negative serum or urine pregnancy test)

Uncontrolled active infection, HIV infection, syphilis serology reaction positive

Active hepatitis B or hepatitis C infection

With severe cardiac, liver, renal insufficiency, diabetes and other diseases

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients would receive autologous CAR-T cell therapy targeting both CD19 and CD22. The dosage for CD19/CD22 bispecific CAR-T cells was 2×10e6/kg.

Study 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

Recruiting

Beijing Tongren Hospital, Capital Medical University

Beijing, ChinaOpen Beijing Tongren Hospital, Capital Medical University in Google Maps
Recruiting
One Study Center