Suspended

Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma

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What is being tested

CD19 CART

Combination Product
Who is being recruted

Hemic and Lymphatic Diseases+6

+ Immune System Diseases

+ Immunoproliferative Disorders

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 2019
See protocol details

Summary

Principal SponsorChinese PLA General Hospital
Study ContactLixing Wang, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2019

Actual date on which the first participant was enrolled.

This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory non-hodgkin lymphoma

Official TitleStudy Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
NCT04012892
Principal SponsorChinese PLA General Hospital
Study ContactLixing Wang, MD
Last updated: January 27, 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

12 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.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 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.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic Type

Criteria

6 inclusion criteria required to participate
Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive

Age 18 to 65 years old, both male and female;

Is expected to survive more than 12 weeks;

Physical condition is good: 0-1 score ECOG score;

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5 exclusion criteria prevent from participating
Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;

Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;

Pregnancy and lactation women;

Patients who have participated in other clinical trials or other clinical trials in the past 30 days;

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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
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10\^4 cells/kg in 36-96 hours

Study Objectives

Primary 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

Shenzhen University General Hospital

Shenzhen, ChinaOpen Shenzhen University General Hospital in Google Maps
SuspendedOne Study Center
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma | PatLynk