GB5005 CART-cell Injection in the Treatment of Patients With CD19-positive RR B-NHL
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
To evaluate the safety and tolerability of GB5005 in patients with CD19-positive relapsed/refractory B-cell non-Hodgkin lymphoma (B-NHL).
Eligibility criteria
Qualifiers
The candidate is able to communicate effectively with researchers and sign informed consent forms in writing;
Age greater than or equal to 18 years old and less than or equal to 70 years old, regardless of gender; Sign informed consent form;
Non Hodgkin lymphoma confirmed by cytology and genetics;
Positive expression of CD19 in tumor cells confirmed by flow cytometry or pathological histology;
Disqualifiers
Patients with a history of allergies to serum albumin and DMSO in the past;
Active hepatitis B virus (HBV) (HBV-DNA positive), hepatitis C virus antibody (HCV) (HCV-RNA positive), or human immunodeficiency virus (HIV) infection;
Within the past 2 years, terminal organ damage caused by autoimmune diseases such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, or the need for systemic use of immunosuppressive or other systemic disease control drugs;
History of unstable angina, myocardial infarction, coronary angioplasty, or significant heart disease within one year of enrollment;
Trial design
Treatments tested in this trial
- GB5005 CART
Treatment groups
45 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov