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| Name | Class |
|---|---|
| Beijing GD Initiative Cell Therapy Technology Co., Ltd. | INDUSTRY |
| Chinese Academy of Medical Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous γδT cells | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous γδT cells | Biological | Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 months |
| Overall response rate (ORR) | Rate of complete remission (CR) and partial remission (PR). | 28 days after infusion of γδT cells |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 months |
| Time to response(TTR) |
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Inclusion Criteria:
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:
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
Patient's cardiac function meets any of the following conditions
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dehui Zou, Dr. | Contact | 86-022-23909283 | zoudehui@ihcams.ac.cn | |
| Shuhua Yi, Dr. | Contact | 86-022-23909106 | yishuhua@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Dehui Zou, Dr. | Institute of Hematology & Blood Disease Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | 300020 | China |
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Biological: Autologous γδT cells Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
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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.
| 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. | 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. | 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. | 15 months |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D016399 | Lymphoma, T-Cell |
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