An Early Phase 1 interventional study of Autologous γδT cells in Non-Hodgkin's Lymphoma, Relapsed or Refractory B Cell Non-Hodgkin's Lymphoma and Chronic Lymphoblastic Leukemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Early Phase 1, Interventional, and Treatment
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.
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 6 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.
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Exclusion Criteria:
Patients receiving chemotherapy within 2 weeks prior to γδT cell infusion, with the following exceptions:
History of other malignant tumors, with the following exceptions
Patient's cardiac function meets any of the following conditions
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.
Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.
Time frame: 15 months
Overall response rate (ORR)
Rate of complete remission (CR) and partial remission (PR).
Time frame: 28 days after infusion of γδT cells
Duration of remission (DOR)
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 frame: 15 months
Time to response(TTR)
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.
Time frame: 15 months
Disease control rate (DCR)
Disease control rate is defined as the proportion of subjects who achieved CR, PR, and disease stability (SD) by imaging evaluation.
Time frame: 15 months
Progression free survival (PFS)
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.
Time frame: 15 months
Overall survival (OS)
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.
Time frame: 15 months
Plan to share: No
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This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Institute of Hematology & Blood Diseases Hospital, China