Suspended
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
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
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: May 2019
Summary
Principal SponsorChinese PLA General Hospital
Study ContactLixing Wang, MD
Last updated: January 27, 2026Sourced 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
Principal SponsorChinese PLA General Hospital
Study ContactLixing Wang, MD
Last updated: January 27, 2026Sourced 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
ExperimentalAfter 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 MapsSuspendedOne Study Center