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γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)

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ClinicalTrials.gov Identifier: NCT04028440
Recruitment Status : Not yet recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
Sponsor:
Collaborator:
Beijing GD Initiative Cell Therapy Technology Co.,Ltd.
Information provided by (Responsible Party):
Zou Dehui, Institute of Hematology & Blood Diseases Hospital

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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma Chronic Lymphoblastic Leukemia Peripheral T Cell Lymphoma Biological: Autologous γδT cells Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Biological: Autologous γδT cells Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preliminary Exploration of γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL).
Estimated Study Start Date : July 20, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2022


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).
Biological: Autologous γδT cells
Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.




Primary Outcome Measures :
  1. 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.

  2. Overall response rate (ORR) [ Time Frame: 28 days after infusion of γδT cells ]
    Rate of complete remission (CR) and partial remission (PR).


Secondary Outcome Measures :
  1. 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.

  2. Time to response(TTR) [ Time Frame: 15 months ]
    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.

  3. Disease control rate (DCR) [ Time Frame: 15 months ]
    Disease control rate is defined as the proportion of subjects who achieved CR, PR, and disease stability (SD) by imaging evaluation.

  4. 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.

  5. 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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients should sign informed consent form voluntarily.
  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:

  1. Patients with history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04028440


Contacts
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Contact: Dehui Zou, Dr. 86-022-23909283 zoudehui@ihcams.ac.cn
Contact: Shuhua Yi, Dr. 86-022-23909106 yishuhua@ihcams.ac.cn

Locations
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China, Tianjin
Institute of Hematology & Blood Diseases Hospital Not yet recruiting
Tianjin, Tianjin, China, 300020
Contact: Dehui Zou, Dr.    86-022-23909283    zoudehui@ihcams.ac.cn   
Contact: Shuhua Yi, Dr.    86-022-23909106    yishuhua@ihcams.ac.cn   
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Beijing GD Initiative Cell Therapy Technology Co.,Ltd.
Investigators
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Principal Investigator: Dehui Zou, Dr. Institute of Hematology & Blood Disease Hospital

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Responsible Party: Zou Dehui, Chief physician, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT04028440     History of Changes
Other Study ID Numbers: QT2019001-EC-2
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, T-Cell, Peripheral
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Lymphoma, T-Cell
Leukemia, B-Cell