Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a total target dose of 410E+6 of CD19-positive CAR T cells as a split dose on Day 1 and on Day 10 (±2 days).

AUTO1

This is a Phase Ib/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).

This Phase Ib/II, open-label, multi-center, single arm study is designed to evaluate the safety and efficacy of AUTO1 in adult patients with B-cell ALL by determining the overall response rate (ORR).

Adult patients with relapsed or refractory ALL will be enrolled in both phases of the study. Consented patients will go through the following five sequential stages: screening, leukapheresis, pre-conditioning, treatment, and follow-up. All patients will receive a total target dose of 410E+6 of CAR T cells as a split dose on Day 1 and on Day 10 (±2 days).

A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating the Safety and Efficacy of AUTO1, a CAR T Cell Treatment Targeting CD19, in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia

Autolus Limited

Symptoms and General Pathology

Recurrence

Leukemia, B-Cell

Immunomodulating Agents

The qualified CD19-targeted CART cells will be transferred to patient for 3 days as follow:D1,10% fraction;D2,30%;D3 60%. The number of CART cells for each course will be about 1×106/kg. If complete response (CR) or complete response with incomplete hemogram recovery (CRi) in hemogram is achieved after the first course of treatment, further treatment will be decided according to the clinical assessment and the wishes of the patient.If partial response (PR) is achieved after the first course, 1 or 2 courses of treatment will be continued. If there is no response (NR) after the first course, the treatment will be ceased or restarted based on the clinical assessment or patients' wishes. Treatent may be discontinued due to any severe toxicity, such as cytokine release syndrom.

CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv.This is a second generation CRAT.

CD19-targeted CART cells

This study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor.

In this single-center, open-label, single-arm, prospective clinical trial, a total of 20 recurrent or refractory CD19+ B cell acute lymphoblastic leukemia patients will be enrolled.After recruiting eligible patients,autologous peripheral blood mononuclear cells(PBMCs) will be purified from whole blood.The CD3+ T cells were subsequently selected and re-stimulated by anti-CD3 and anti-CD28 monoclonal antibodies.T cells will be transduced with lentiviral vector for the generation of the CD19 CART cell and administered by i.v. injection.The purpose of current study is to determine the safety and clinical efficacy of CD19 CAR T cells therapy in patients with recurrent or refractory CD19+ ALL.

Patients with recurrent or refractory CD19+ ALL receive CD19 CAR T-cell immunotherapy.

Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia

Safety and Clinical Activity of CD19 Chimeric Antigen Receptor T Cells in Treating Patients With Recurrent or Refractory CD19 Positive B Cell Acute Lymphoblastic Leukemia

ORR is defined as the proportion of partial responses plus complete responses.

Progression-free survival is defined as the time from enrollment to first observation of progression or date of death (from any cause).

Overall survival, defined as the time from enrollment until death due to any cause. For patients who do not die, time to death will be censored at the time of last contact.

jiuwei cui

chief

Behaviors and Mental Disorders

Nervous System Diseases

Lymphoma, B-Cell

Aggression

Lymphoma, Non-Hodgkin

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

B-cell Lymphoma

Childhood Acute Lymphoblastic Leukemia

Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells

Autolus Ltd

Dr Juliana Silva, MD

This is a Phase Ib study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in pediatric patients with relapsed or refractory B cell acute lymphoblastic leukemia (B ALL) and relapsed or refractory B cell Non-Hodgkin lymphoma (B NHL)

This is a single-arm, open-label, multi-center, Phase Ib study to determine the safety and preliminary efficacy of AUTO1 administered intravenously in pediatric patients with r/r B ALL and with r/r aggressive mature B NHL. This study is designed to evaluate the safety and preliminary efficacy of AUTO1.

The safety and tolerability of AUTO1 in pediatric patients will be continually monitored by the Sponsor. Additionally, the Independent Data Monitoring Committee (IDMC) will review the rolling safety data generated after 6 and 12 treated patients have been monitored for at least 28 days and in the event any protocol defined safety stopping criteria are met. If no pre-defined safety events related to AUTO1 are met, and the safety data are consistent with what has previously been observed with AUTO1, the IDMC can recommend continuing the study without or with modifications. Based on emerging data, the study may be stopped early due to excessive toxicity, i.e. certain pre-defined AUTO1-related safety events or deaths.

The study will involve consented patients going through the following sequential study periods: screening, leukapheresis, bridging as necessary, pre-conditioning, treatment evaluation, and follow-up.

A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)

A Single-Arm, Open-Label, Multi-Centre, Phase Ib Study Evaluating the Safety and Preliminary Efficacy of AUTO1 in Pediatric Patients With CD19-Positive Relapsed/ Refractory (r/r) B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL)

Defined as best response of complete remission or complete remission with incomplete recovery of counts per Investigator assessment occurring at any time after AUTO1 infusion

Defined as best response of complete response or partial response per Investigator assessment occurring at any time after AUTO1 infusion

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)	NCT04404660	Relapsed or Ref...	AUTO1	18 Years -	Autolus Limited
Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia	NCT03599375	Leukemia, B-Cel...	CD19-targeted C...	14 Years - 75 Years	The First Hospital of Jilin University
Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia	NCT03599375	Leukemia, B-Cel...	CD19-targeted C...	14 Years - 75 Years	The First Hospital of Jilin University
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)	NCT06173518	Relapsed or Ref... Relapsed or Ref...	AUTO1	0 Years - 18 Years	Autolus Limited

Spots Global Cancer Trial Database for refractory b cell acute lymphoblastic leukemia