Status:
UNKNOWN
γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
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
Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
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 peri...
Detailed Description
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, scree...
Eligibility Criteria
Inclusion
- Patients should sign informed consent form voluntarily.
- Gender unlimited, age ≥ 18 years old.
- 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.
- Patients had an evaluable imaging lesion of at least greater than 1.5 cm (except CLL).
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
- Adequate bone marrow function as defined by：Absolute neutrophil count (ANC) \>1000/mm3；Absolute lymphocyte count (ALC) ≥300/mm3；Platelet ≥50000/mm3；Hemoglobin \>8.0g/dl.
- Adequate end organ function as defined by: Total bilirubin ≤ 2 x upper limit of normal（ULN）; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN; Creatinine ≤ 1.5 x ULN or any serum creatinine level associated with a measured or calculated creatinine clearance of ≥ 60ml/min.
- Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
Exclusion
- Patients with history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- Active central nervous system (CNS) lymphoma; Patients with symptoms of CNS disease must undergo lumbar puncture and brain nuclear magnetic resonance to exclude CNS lymphoma.
- Patients receiving chemotherapy within 2 weeks prior to γδT cell infusion, with the following exceptions:
- Pretreatment chemotherapy prescribed by the protocol
- In order to prevent CNS intrathecal chemotherapy (should be stopped 1 week before γδT cell therapy)
- Other exploratory combined medications
- Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.
- Active chronic hepatitis B or hepatitis C virus infection, active cytomegalovirus (CMV), EBV infection.
- Major surgery that was evaluated by the investigator as unsuitable for inclusion within 4 weeks prior to screening.
- History of other malignant tumors, with the following exceptions
- Excisional non-melanoma (e.g. cutaneous basal cell carcinoma)
- Cured situ carcinoma (e.g. cervical carcinoma)
- Localized prostate cancer with radiotherapy or surgery
- Patients with a history of malignant tumors, but the disease has been cured for ≥2 years
- Patient's cardiac function meets any of the following conditions
- Left ventricular ejection fraction (LVEF) ≤45%
- Class III or IV heart failure according to the NYHA Heart Failure Classifications
- QTcB\>450 msec
- Other cardiac disease that investigators judge is not suitable for enrollment
- History of epilepsy or other active central nervous system disorders.
- Inoculated live vaccine within 6 weeks before screening.
- Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia).
- Patients are allergic to cytokines.
- Expected survival \< 12 weeks.
- Participated in any other interventional clinical trial within three months.
- Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04028440
Start Date
October 1 2019
End Date
March 31 2022
Last Update
September 26 2019
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020