Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Lymphosarcoma

Peripheral T-cell Lymphoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Lymphocytic Leukemia

B-cell Lymphoma

All Drugs and Chemicals

Immunomodulating Agents

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).

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

Autologous γδT cells

Dehui Zou, Dr.

Shuhua Yi, Dr.

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.

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

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).

Incidence of adverse events (AEs) and serious adverse events (SAEs) of each patient will be recorded and analyzed.

Rate of complete remission (CR) and partial remission (PR).

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 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 is defined as the proportion of subjects who achieved CR, PR, and disease stability (SD) by imaging evaluation.

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 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.

Beijing GD Initiative Cell Therapy Technology Co., Ltd.

Chinese Academy of Medical Sciences

Institute of Hematology & Blood Diseases Hospital, China

Chief physician

Digestive System Diseases

Infections

Carcinoma

Carcinoma, Hepatocellular

Hepatitis A

Hepatitis

Hepatitis B

Neoplasms, Glandular and Epithelial

Liver Diseases

Gastrointestinal Diseases

Hepatitis, Viral, Human

Virus Diseases

Communicable Diseases

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Blood-Borne Infections

Hepadnaviridae Infections

DNA Virus Infections

Subjects will receive 3 cycles of γδT cells treatments, at four-week intervals, each cycle has 2 infusions.

Dose escalation subjects will receive 6 infusions with dose of γδT cells escalation from 1×10e9 to 6×10e9.

Constant dose subjects will have single infusion intravenously at a target dose of 1\~2×10e9 γδT cells.

autologous γδT cells

Yuanyuan Li, Dr

Fu-Sheng Wang, MD

Fu-Sheng Wang, Dr

To evaluate the safety, tolerability and efficacy of autologous γδT cells in the treatment of advanced hepatitis B-related hepatocellular carcinoma.

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, fresh biopsy and screening, apheresis, γδT cells preparation, treatment and follow-up. The study will evaluate the safety, tolerability and efficacy of autologous γδT cells in patients with advanced hepatitis B related hepatocellular carcinoma (HCC) which are refractory to current treatment.

Stage I comprising a safety cohort of patients to identify a safe dose, Stage II comprising an expanded patient group for response signal identification, Stage III to confirm efficacy and safety.

Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells

The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the response evaluation criteria in solid tumors (RECIST) guideline.

According to the European Organization for Research and Treatment of Cancer (EORTC) quality of life of the core scale criteria QLQ-C30 to evaluate and compare patients life quality before and after treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)	NCT04028440	Non-Hodgkin's L... Relapsed or Ref... Chronic Lymphob... Peripheral T Ce...	Autologous γδT ...	18 Years - 75 Years	Institute of Hematology & Blood Diseases Hospital, China
γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)	NCT04028440	Non-Hodgkin's L... Relapsed or Ref... Chronic Lymphob... Peripheral T Ce...	Autologous γδT ...	18 Years - 75 Years	Institute of Hematology & Blood Diseases Hospital, China
Immunotherapy of Advanced Hepatitis B Related Hepatocellular Carcinoma With γδT Cells	NCT04032392	Hepatocellular ...	autologous γδT ...	18 Years - 70 Years	Beijing 302 Hospital
γδT Cells Immunotherapy in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)	NCT04028440	Non-Hodgkin's L... Relapsed or Ref... Chronic Lymphob... Peripheral T Ce...	Autologous γδT ...	18 Years - 75 Years	Institute of Hematology & Blood Diseases Hospital, China

Spots Global Cancer Trial Database for autologous γδt cells