γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04028440|
Recruitment Status : Not yet recruiting
First Posted : July 22, 2019
Last Update Posted : July 22, 2019
|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|
|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)|
|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|
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.
- 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.
- Overall response rate (ORR) [ Time Frame: 28 days after infusion of γδT cells ]Rate of complete remission (CR) and partial remission (PR).
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Dehui Zou, Dr.||email@example.com|
|Contact: Shuhua Yi, Dr.||firstname.lastname@example.org|
|Institute of Hematology & Blood Diseases Hospital||Not yet recruiting|
|Tianjin, Tianjin, China, 300020|
|Contact: Dehui Zou, Dr. 86-022-23909283 email@example.com|
|Contact: Shuhua Yi, Dr. 86-022-23909106 firstname.lastname@example.org|
|Principal Investigator:||Dehui Zou, Dr.||Institute of Hematology & Blood Disease Hospital|