- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028440
γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
September 24, 2019 updated by: Zou Dehui, Institute of Hematology & Blood Diseases Hospital
Preliminary Exploration of γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL).
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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, screening and registration to the trial, apheresis, γδT cells preparation, pre-treatment for lymphodepleting chemotherapy (selectable plan), treatment and follow-up.
The study will evaluate the safety and efficacy of the 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.
Study Type
Interventional
Enrollment (Anticipated)
6
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dehui Zou, Dr.
- Phone Number: 86-022-23909283
- Email: zoudehui@ihcams.ac.cn
Study Locations
-
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Tianjin
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Tianjin, Tianjin, China, 300020
- Recruiting
- Institute of Hematology & Blood Diseases Hospital
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Contact:
- Dehui Zou, Dr.
- Phone Number: 86-022-23909283
- Email: zoudehui@ihcams.ac.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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).
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Cells will be extracted by apheresis, followed by expanding and activating.
The autologous γδT cells product will be adoptive transferred.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Severe/Adverse Events as a Measure of Safety.
Time Frame: 15 months
|
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
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15 months
|
Overall response rate (ORR)
Time Frame: 28 days after infusion of γδT cells
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Rate of complete remission (CR) and partial remission (PR).
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28 days after infusion of γδT cells
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of remission (DOR)
Time Frame: 15 months
|
Duration of remission is defined as the time from the first occurrence of CR or PR in the tumor assessment to the first occurrence of disease progression (PD) or death.
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15 months
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Time to response(TTR)
Time Frame: 15 months
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Time to response is defined as the time from the first administration of trial drug to the first occurrence of CR or PR in the tumor assessment.
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15 months
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Disease control rate (DCR)
Time Frame: 15 months
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Disease control rate is defined as the proportion of subjects who achieved CR, PR, and disease stability (SD) by imaging evaluation.
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15 months
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Progression free survival (PFS)
Time Frame: 15 months
|
Progression free survival is defined as the time from the day in which the patient is enrolled to the date on which tumor progresses or the date on which the patient dies for any cause.
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15 months
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Overall survival (OS)
Time Frame: 15 months
|
Overall survival is defined as the time from the day in which the patient is enrolled to the date on which the patient dies for any cause.
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15 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dehui Zou, Dr., Institute of Hematology & Blood Disease Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2019
Primary Completion (ANTICIPATED)
December 31, 2020
Study Completion (ANTICIPATED)
March 31, 2022
Study Registration Dates
First Submitted
July 18, 2019
First Submitted That Met QC Criteria
July 19, 2019
First Posted (ACTUAL)
July 22, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 26, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia, Lymphoid
- Leukemia
- Leukemia, B-Cell
- Lymphoma, T-Cell
- Lymphoma
- Lymphoma, B-Cell
- Lymphoma, Non-Hodgkin
- Leukemia, Lymphocytic, Chronic, B-Cell
- Lymphoma, T-Cell, Peripheral
Other Study ID Numbers
- QT2019001-EC-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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