γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
Preliminary Exploration of γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL).
1 other identifier
interventional
6
1 country
1
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 peripheral T cell lymphoma (PTCL) expect for γδT lymphoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Oct 2019
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2019
CompletedFirst Posted
Study publicly available on registry
July 22, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2022
CompletedSeptember 26, 2019
July 1, 2019
1.3 years
July 18, 2019
September 24, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants with Severe/Adverse Events as a Measure of Safety.
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
15 months
Overall response rate (ORR)
Rate of complete remission (CR) and partial remission (PR).
28 days after infusion of γδT cells
Secondary Outcomes (5)
Duration of remission (DOR)
15 months
Time to response(TTR)
15 months
Disease control rate (DCR)
15 months
Progression free survival (PFS)
15 months
Overall survival (OS)
15 months
Study Arms (1)
Autologous γδT cells
EXPERIMENTALSubjects 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).
Interventions
Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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%
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dehui Zou, Dr.
Institute of Hematology & Blood Disease Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician
Study Record Dates
First Submitted
July 18, 2019
First Posted
July 22, 2019
Study Start
October 1, 2019
Primary Completion
December 31, 2020
Study Completion
March 31, 2022
Last Updated
September 26, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share