This study aims to evaluate the safety and efficacy of autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
This is a single-centre, non-randomised, open label, no control, prospective clinical trial. The study will include the following sequential phases: sign informed consent, γδT cells pre-culture, screening and registration to the trial, apheresis, γδT cells preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatment and follow-up. The study will evaluate the safety and efficacy of the autologous γδT cells in patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL), chronic lymphoblastic leukemia (CLL) and peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGNumber of Participants with Severe/Adverse Events as a Measure of Safety.
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
Time frame: 15 months
Overall response rate (ORR)
Rate of complete remission (CR) and partial remission (PR).
Time frame: 28 days after infusion of γδT cells
Duration of remission (DOR)
Duration of remission is defined as the time from the first occurrence of CR or PR in the tumor assessment to the first occurrence of disease progression (PD) or death.
Time frame: 15 months
Time to response(TTR)
Time to response is defined as the time from the first administration of trial drug to the first occurrence of CR or PR in the tumor assessment.
Time frame: 15 months
Disease control rate (DCR)
Disease control rate is defined as the proportion of subjects who achieved CR, PR, and disease stability (SD) by imaging evaluation.
Time frame: 15 months
Progression free survival (PFS)
Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.
Time frame: 15 months
Overall survival (OS)
Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.
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Time frame: 15 months