This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive lymphoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the CD19 protein on the cell surface. The study will determine if these modified T cells help the body's immune system eliminate tumour cells .The trial will also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.
This is an open, single-arm,multicenter 2 phase clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of CD19 positive lymphoma. The study will be conducted using a phaseⅠ/Ⅱdesign the study will have the following sequential phases: part A (screening, leukapheresis, cell product preparation and cytoreductive chemotherapy) and part B (treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion. The total duration of the study are expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months.
Jiangsu Cancer hospital
Nanjing, Jiangsu, China
The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy.
The objective reaction rate will be determined by the evaluation of CT/PET-CT.Evaluation of the objective reaction rate according to the non-hodgkin's lymphoma curative effect evaluation criteria of international lymphoma group. The objective reaction rate = (complete remission (CR) number + partial remission (PR) number / total number of cases receiving treatment.
Time frame: up to 90 days
Progression free survival time
From patients into the group to the interval between disease progression or death.
Time frame: 3years
Overall survival time
From all patients into the group to the interval between death caused by any reason .
Time frame: 3years
Patients - -based Quality of Life Evaluation
According to the EORTC quality of life of the core scale criteria QLQ-C30(V3.0) to evaluate patients life quality.
Time frame: 3years
3°or above incidence rate of serious adverse reaction related to treatment
According to CTCAE v4.0 to evaluate incidence rate of serious adverse reaction.
Time frame: 3years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.