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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
GB5005 CART
DrugIncluded patients will receive GB5005 chimeric antigen receptor T-cell injection: A sterile syringe will be used to draw the assigned dose volume (calculated based on the patient's weight and converted to volume). The cells will be slowly infused intravenously at a rate of about 10 mL/min.
Treatment groups
45 Participants
are divided into 4 treatment groupsGroup A: Low dose groupExperimental treatment 1 intervention
Group B: Median dose groupExperimental treatment 1 intervention
Group C: Medium to high dose groupExperimental treatment 1 intervention
Group D: High dose groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete remission (CR)
Complete remission rate was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Time frame
Up to 3 monthsSecondary outcomes
1
Recurrence free survival time (RFS)
Recurrence free survival time was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first. PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease recurrence or date of death from any cause, whichever occurs first. PFS was defined as the time from the date of treatment initiation to the date of first documentation of definitive disease progression (PD) or date of death from any cause, whichever occurs first.
Time frame
Up to 24 months2
Overall survival（OS）
Overall survival will be measured from the date of registration to the date of the event (i.e., death) or the date of last follow-up to evaluate that event. Patients who are event-free at their last follow-up evaluation will be censored at that time point.
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov