Symptoms and General Pathology

All Conditions

Recurrence

Disease Attributes

All patient will receive modified CAR19 T-cells.

The original stem cells donor (or if not available the patient) will undergo unstimulated leucapheresis for generation of the Advanced Therapy Interventional Medicinal Product (ATIMP) 4G7-CARD T-cells. Escalating doses of the ATIMP will then be infused to the patient depending on outcome and any experienced side effects.

Infusion of modified CAR19 T-cells (4G7-CARD T-cells)

Karl Peggs

Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels planned.

Patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually for years 2 and 3.

Patients will receive escalating doses of 4G7-CARD T-cells (after pre-conditioning with Fludarabine and Cyclophosphamide), paralleling clinical standard of care with unmanipulated donor lymphocytes. Intra-patient dose escalation will proceed at intervals of not less than 8 weeks, dependent on development of toxicity or evidence of efficacy and confirmation by the Trial Management Group.

Three dose cohorts levels are planned, and dosing will be according to total CD3+ T- cell dose as this correlates with toxicity in the unmanipualated donor lymphocyte setting:

* Dose Level 1: 1x10\^6 CD3+ T-cells/kg (starting dose for all patients)
* Dose Level 2: 3x10\^6 CD3+ T-cells/kg
* Dose Level 3: 1x10\^7 CD3+ T-cells/kg

The inter-patient dosing for the first 3 patients was at least 28 days, following TMG confirmation.

Patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4G7-CARD T-cell infusion. During the long term follow up phase of the study (years 2-3 post-final 4G7-CARD T-cell infusion) patients will be followed-up annually for overall survival, disease status and safety.

All patients will enter long term follow up until 3 years post-final 4G7-CARD T-cell infusion.

CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation

Chimeric Antigen Receptor (CAR)19 Donor Lymphocytes for Relapsed Cluster of Differentiation (CD)19+ Malignancies Following Allogeneic Transplantation (CARD)

The number of ATIMP successfully manufactured would be assessed for all registered patients

Toxicity evaluation following 4G7-CARD T-cell administration as evaluated by the occurrence of adverse events per studied dose using CTCAE v4.03, defined as \>grade 2 events that are causally related to study treatment or procedure or Serious Adverse Reactions that require withdrawal of the patient from the study; development and severity of graft-versus-host-disease (GvHD) following cell infusion will also be evaluated as a potential toxicity, as well as development and severity of cytokine release syndrome / macrophage activation syndromes assessed by 'University of Pennsylvania' criteria

Data for engraftment and expansion would be summarised by mean, median or interquartile ranges and a Kaplan Meier plot for persistence

Data would be summarised using means (medians) and as the percentage reduction from baseline

Data on timing (kinetic of change) and magnitude of cytokine levels can be summarised using means (medians) and plots for each patients

University College, London

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Neoplasms by Histologic Type

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)

allogeneic CART-19

Huisheng Ai, MD

Weidong Han, MD

The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)

The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.

Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL

Treatment of Elderly Relapsed and/or Refractory CD19-positive Acute Lymphoblastic Leukemia by Infusions of Allogeneic CART-19

defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria

An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR

Chinese PLA General Hospital

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Lymphoma

Hematologic Neoplasms

Lymphoma, B-Cell

Leukemia, B-Cell

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

B-cell Lymphoma

Lymphosarcoma

Experimental: CD19 CART cell.The target dose range administered in this study is 1x10e5-1x10e7 CART-19 cells/kg.

Patients will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. The target dose range administered in this study is 1x10e5-1x10e7 CD19CART cells/kg. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.

CD19CART

Lei Xiao, Ph.D

Yu Hu, Ph.D

He Huang, Ph.D

This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy.

This single arm, open-label, multi-center clinical trial is studying CD19 targeted chimeric antigen receptor T cells therapy in treating patients with CD19 positive malignant B-cell derived leukemia and lymphoma that is relapsed (after stem cell transplantation or chemotherapy) or refractory to chemotherapy. When patients enroll in this trial, autologous CD19CART cells were generated from the mononuclear cells of the patient's peripheral blood (PB). During the term of cell preparation of CD19CART cells, patients will receive a conditioning regimen. One day after completing conditioning regimen, the patient will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.

Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B Cell Hematologic Malignancies

A Multicenter Efficacy and Safety Study of Cluster of Differentiation 19 (CD19)-Targeted CART (CD19CART) Therapy for CD19 Positive Relapsed or Refractory B-cell Hematologic Malignancies (SCT019-01）

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation	NCT02893189	CD19+ Malignanc...	Infusion of mod...	16 Years - 70 Years	University College, London
Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL	NCT02799550	Leukemia	allogeneic CART...	60 Years -	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Chimeric Antigen Receptor T Cells (CART) Therapy in Refractory/Relapsed B Cell Hematologic Malignancies	NCT02813837	Leukemia, B-Cel... Lymphoma, B-Cel...	CD19CART	- 60 Years	Innovative Cellular Therapeutics Co., Ltd.
Allogeneic CART-19 for Elderly Relapsed/Refractory CD19+ ALL	NCT02799550	Leukemia	allogeneic CART...	60 Years -	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation	NCT02893189	CD19+ Malignanc...	Infusion of mod...	16 Years - 70 Years	University College, London

Spots Global Cancer Trial Database for cd19+

Every month we try and update this database with for cd19+ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cd19+

Every month we try and update this database with for cd19+ cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cd19+ cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.