γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT04028440
Last Updated: 2019-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
6 participants
INTERVENTIONAL
2019-10-31
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Autologous γδT cells
Subjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions, single infusion intravenously at a target dose of 1\~2×10e9 γδT cells (constant dose).
Autologous γδT cells
Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
Interventions
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Autologous γδT cells
Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
Eligibility Criteria
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Inclusion Criteria
2. Gender unlimited, age ≥ 18 years old.
3. 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.
4. Patients had an evaluable imaging lesion of at least greater than 1.5 cm (except CLL).
5. Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
6. 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.
7. 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.
8. Male and female of reproductive potential must agree to use birth control during the study and for at least 6 weeks post study.
Exclusion Criteria
2. 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.
3. 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
4. Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.
5. Active chronic hepatitis B or hepatitis C virus infection, active cytomegalovirus (CMV), EBV infection.
6. Major surgery that was evaluated by the investigator as unsuitable for inclusion within 4 weeks prior to screening.
7. 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
8. 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
9. History of epilepsy or other active central nervous system disorders.
10. Inoculated live vaccine within 6 weeks before screening.
11. Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia).
12. Patients are allergic to cytokines.
13. Expected survival \< 12 weeks.
14. Participated in any other interventional clinical trial within three months.
15. Any situation that investigators believe the risk of the subjects is increased or results of the trial are disturbed.
18 Years
75 Years
ALL
No
Sponsors
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Beijing GD Initiative Cell Therapy Technology Co., Ltd.
INDUSTRY
Chinese Academy of Medical Sciences
OTHER
Institute of Hematology & Blood Diseases Hospital, China
OTHER
Responsible Party
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Zou Dehui
Chief physician
Principal Investigators
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Dehui Zou, Dr.
Role: PRINCIPAL_INVESTIGATOR
Institute of Hematology & Blood Disease Hospital
Locations
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Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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QT2019001-EC-2
Identifier Type: -
Identifier Source: org_study_id
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