Status:
UNKNOWN
Allogeneic γδ T Cells Immunotherapy in r/r Non-Hodgkin's Lymphoma (NHL) or Peripheral T Cell Lymphomas (PTCL) Patients
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Beijing GD Initiative Cell Therapy Technology Co., Ltd.
Chinese Academy of Medical Sciences
Conditions:
Non-Hodgkin's Lymphoma (NHL)
Peripheral T Cell Lymphoma (PTCL)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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-Hodgki...
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 bloo...
Eligibility Criteria
Inclusion
- Patient
- Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
- Age≥18 years old, gender unlimited.
- Patients whose relatives are willing to donate PBMCs voluntarily.
- Patients with relapsed or refractory B cell non-Hodgkin's lymphoma (B-NHL) or peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
- Patients had an evaluable imaging lesion of at least greater than 1.5 cm.
- Eastern Cooperative Oncology Group (ECOG) Performance score≤2.
- Adequate bone marrow function:
- Absolute neutrophil count (ANC) \>1000/mm3;
- Absolute lymphocyte count (ALC)≥300/mm3;
- PLT≥50,000/mm3;
- Hb \>8.0g/dl.
- 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.
- 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
- Sign informed consent form.
- Age 18 years up to the age of 60 (≤60), gender unlimited.
- Relatives of patients (unrestricted to blood relationship).
- Apheresis available.
- PLT≥100×109/L with normal APTT or PT.
Exclusion
- Patient
Key Trial Info
Start Date :
December 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 25 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04696705
Start Date
December 31 2020
End Date
December 25 2023
Last Update
January 6 2021
Active Locations (1)
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1
Institute of Hematology & Blood Disease Hospital
Tianjin, Tianjin Municipality, China, 300020