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

Hematologic Neoplasms

Acute Graft Versus Host Disease

Antineoplastic Agents

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will received lymphodepletion with fludarabine (30 mg/kg) and cyclophosphamide (300 mg/kg) on days -5, -4, and -3, followed by the infusions of AT19 cells on day 0-2. The study will be divided into three groups: B-ALL, B-CLL, and B-cell lymphoma. Doses of 0.5×10\^7, 1.0×10\^7, and 2.0×10\^7 CAR+ T cells (with an allowance of ±20%) will be tested in each group in the 3+3 dose-escalation study. Each dose group has 3 patients. If no DLT emerges in the group, then the next group uses the subsequent higher dose. If DLT emerges in a single subject in any dose level, 3 more subjects will be enrolled to the same dose level.The maximum dose could be extended.

fludarabine 30 mg/kg on day -5, -4, and -3; cyclophosphamide 300 mg/kg on day -5, -4, and -3; CAR-NK-CD19 Cells on day 0.

Fludarabine + Cyclophosphamide + CAR-NK-CD19 Cells

Heng Mei, M.D., Ph.D

Chenggong Li

This is a single-center, open-label, single-arm study to evaluate the primary safety and efficacy of universal chimeric antigen receptor-modified AT19 cells in patients with relapsed or refractory hematological malignancies.

* Adoptive transfer of autologous anti-CD19 CAR-T cells can induce durable remissions in patients with relapsed/refractory hematologic malignancies, including CD19+ B-cell acute lymphoblastic leukemia(B-ALL), B-cell chronic lymphoblastic leukemia(B-CLL), and B-cell lymphoma.
* However, multiple challenges exist for manufacturing CAR-T cells from patients with advanced disease including inability to manufacture a product, disease progression or death while waiting for the CAR-T product to be available, and heterogeneity among autologous CAR-T products that contributes to unpredictable and variable clinical activity.
* Healthy donor T cells can provide a source for production of universal CAR-T cells when combined with gene editing to prevent expression of endogenous TCRs and avoid generation of GvHD in HLA mismatched recipients.
* Cord blood derived T cells from healthy donor are the source for production of universal anti-CD19 CAR-modified AT19 cells. CRISPR/cas9 gene-editing technology has been used to knockout TCRs and HLA-I to avoid GvHD and transplant rejection.
* AT19 cells have exhibited potent cytotoxicity in CD19+ tumor cells and can effectively eradicate CD19+ tumor cells in xenograft mice models, without showing GvHD.
* This study aims to evaluate prelimary safety and efficacy of the universal AT19 cells in patients with relapsed/refractory B-ALL, B-CLL, and B-cell lymphoma.

Universal Chimeric Antigen Receptor-modified AT19 Cells for CD19+ Relapsed/Refractory Hematological Malignancies

Safety and Efficacy of Universal Chimeric Antigen Receptor-modified AT19 Cells in Patients With CD19+ Relapsed/Refractory Hematological Malignancies: a Single-center, Open-label, Single-arm Clinical Study

Quantity of AT19 CAR copies in bone marrow and peripheral blood will be determined by using qPCR.

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

ORR will be assessed from CAR T cell infusion to death or last follow-up (censored).

CRR will be assessed from CAR T cell infusion to death or last follow-up (censored).

PFS will be assessed from CAR T cell infusion to death or last follow-up (censored).

DOR will be assessed from CAR T cell infusion to death or last follow-up (censored).

OS will be assessed from CAR T cell infusion to death or last follow-up (censored).

Chengdu USino Technology Biology Co., Ltd

Wuhan Union Hospital, China

Proferssor, Cheif Doctor

Antibodies

Antibodies, Monoclonal

Immunoglobulins

6 Dosing groups: 125mg/m2 weekly x 4, 250mg/m2 weekly x 4, 375mg/m2 weekly x 4, 500mg/m2 weekly x 4, 500mg/m2 3 times first week then weekly x 3, 500mg/m2 3 times per week x 4

IDEC-152

To determine what side effects and what clinical effects if any the administration of this investigational product, IDEC-152 (an antibody against CD23 which is an important protein on leukemia cells and certain cells in the body's immune system), has on the CLL patient population.

Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)

A Phase I Multicenter, Dose-Escalation Study of IDEC-152 (Anti-CD23 Monoclonal Antibody) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

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
Universal Chimeric Antigen Receptor-modified AT19 Cells for CD19+ Relapsed/Refractory Hematological Malignancies	NCT04796688	Acute Lymphobla... Chronic Lymphob... B-cell Lymphoma	Fludarabine + C...	14 Years - 78 Years	Wuhan Union Hospital, China
Safety and Efficacy of IDEC-152 in the Treatment of Chronic Lymphocytic Leukemia (CLL)	NCT00046488	Chronic Lymphoc...	IDEC-152	18 Years -	Biogen
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 chronic lymphoblastic leukemia