This study aims to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells obtained from a blood-related donor of patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
This study is a single-center, non-randomized, open label, no control, prospective clinical trial to evaluate the safety, tolerability and efficacy of ex-vivo expanded allogeneic γδT cells from a blood-related donor of NHL or PTCL patients(except for γδT lymphoma). This study will include the following sequential phases: sign informed consent, γδT cell pre-culture, screening and registration to the trial, apheresis, γδT cell preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatments and follow-ups. The study will evaluate the safety and efficacy of the ex-vivo expanded allogeneic γδT cells in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.
Institute of Hematology & Blood Disease Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGSafety evaluation: Incidence of Adverse events (AEs)
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Time frame: 2 years post γδT cells infusion
Safety evaluation: Dose limited toxicity (DLTs)
The incidence of DLTs will be recorded and assessed.
Time frame: 28 days
Safety evaluation: Maximum-tolerated dose (MTD)
MTD or clinical recommended dose will be recorded and evaluated.
Time frame: 28 days
Efficacy evaluation:Overall response rate (ORR)
ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.
Time frame: 2 years post γδT cells infusion
Efficacy evaluation:Disease control rate (DCR)
DCR is defined as the incidence of either a CR, a partial response (PR) or stable disease (SD) per the Lugano Classification as determined by study investigators.
Time frame: 2 years post γδT cells infusion
Efficacy evaluation:Duration of remission (DOR)
DOR is defined only for participants who experience an objective response after γδT cells infusion and is the time from the first objective response to disease progression or death from any cause.
Time frame: 2 years post γδT cells infusion
Efficacy evaluation:Progression free survival (PFS)
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PFS is defined as the time from the γδT cells infusion date to the date of disease progression or death from any cause.
Time frame: 2 years post γδT cells infusion
Efficacy evaluation:Overall survival (OS)
OS is defined as the time from γδT cells infusion to the date of death from any cause.
Time frame: 2 years post γδT cells infusion
Pharmacokinetics (PK) evaluation :γδT cells in peripheral blood
Number of γδT cells in peripheral blood will be assessed by flow cytometry.
Time frame: 2 years post γδT cells infusion