Non-Hodgkin's Lymphoma (NHL), Peripheral T Cell Lymphoma (PTCL)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALEx-vivo expanded allogeneic γδT cells
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.
Sponsors
Beijing GD Initiative Cell Therapy Technology Co., Ltd.
Chinese Academy of Medical Sciences
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient Inclusion Criteria: 1. Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study. 2. Age≥18 years old, gender unlimited. 3. Patients whose relatives are willing to donate PBMCs voluntarily. 4. Patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma. 5. Patients had an evaluable imaging lesion of at least greater than 1.5 cm. 6. Eastern Cooperative Oncology Group (ECOG) Performance score≤2. 7. Adequate bone marrow function: * Absolute neutrophil count (ANC) \>1000/mm3; * Absolute lymphocyte count (ALC)≥300/mm3; * PLT≥50,000/mm3; * Hb \>8.0g/dl. 8. Adequate organ function: * Alanine aminotransferase (ALT)≤3 times the upper limit of normal (ULN); * Aspartate aminotransferase (AST)≤3 times ULN * TBIL≤1.5 times ULN (Gilbert syndrome patients TBIL≤3 times ULN and DBIL≤1.5 times ULN) * Scr≤1.5 times ULN or CCR≥60 mL/min/1.73m3 Note: apart from tumor infiltrated liver dysfunction. 9. Male and female patients of reproductive potential must agree to use birth control during the study and for at least 12 weeks post study. * Donor Inclusion Criteria: 1. Sign informed consent form. 2. Age 18 years up to the age of 60 (≤60), gender unlimited. 3. Relatives of patients (unrestricted to blood relationship). 4. Apheresis available. 5. PLT≥100×109/L with normal APTT or PT.
Exclusion criteria
* Patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety evaluation: Incidence of Adverse events (AEs) | 2 years post γδT cells infusion | 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). |
| Safety evaluation: Dose limited toxicity (DLTs) | 28 days | The incidence of DLTs will be recorded and assessed. |
| Safety evaluation: Maximum-tolerated dose (MTD) | 28 days | MTD or clinical recommended dose will be recorded and evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy evaluation：Progression free survival (PFS) | 2 years post γδT cells infusion | PFS is defined as the time from the γδT cells infusion date to the date of disease progression or death from any cause. |
| Efficacy evaluation：Overall response rate (ORR) | 2 years post γδT cells infusion | ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators. |
| Pharmacokinetics (PK) evaluation :γδT cells in peripheral blood | 2 years post γδT cells infusion | Number of γδT cells in peripheral blood will be assessed by flow cytometry. |
| Efficacy evaluation：Overall survival (OS) | 2 years post γδT cells infusion | OS is defined as the time from γδT cells infusion to the date of death from any cause. |
| Efficacy evaluation：Disease control rate (DCR) | 2 years post γδT cells infusion | 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. |
| Efficacy evaluation：Duration of remission (DOR) | 2 years post γδT cells infusion | 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. |
Countries
China
Contacts
Primary ContactDehui Zou, MD
Backup ContactWei Liu, MD
Outcome results
None listed