Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

Blinatumomab

Muromonab-CD3

Antibodies, Bispecific

Immunologic Factors

Patients received blinatumomab as continuous intravenous infusion for 4 weeks. Participants with clinical benefit were permitted to continue for another 4 weeks for a total of 8 weeks. Participants with a clinical benefit 4 weeks after completion of the first cycle of treatment could also receive additional treatment approximately 3 months ater the end of infusion at the same dose level.

Doses from 0.5 to 120 µg/m\^2/24hours by continuous intravenous infusion

Blinatumomab (MT103)

Ralf Bargou, MD, PhD

The purpose of this study is to determine whether a continuous infusion of Blinatumomab (MT103) is safe in the treatment of relapsed Non-Hodgkin's Lymphoma.

Furthermore, the study is intended to provide pharmacokinetic and pharmacodynamic data of Blinatumomab as well as to get first indication of tumour activity.

Non-Hodgkin's Lymphoma (NHL) represents the 6th most common cancer. Globally, around 165,000 new cases are diagnosed each year, with approximately 90,000 deaths per year. The vast majority of NHLs are B-cell derived (90%) and express common B-cell antigens such as CD19, CD20 and CD22. NHL can be divided into indolent (low-grade) and aggressive (high-grade) lymphomas. Still almost all patients with advanced stage indolent disease will die from their disease. Therefore, a high medical need exists to develop novel agents that further improve the survival of NHL patients.

Blinatumomab (MT103) is a bispecific antibody derivative, anti-CD19 x anti-CD3, designed to link B-cells and T-cells resulting in T-cell activation and a cytotoxic T-cell response against CD19+ cells. Data of prior phase I studies show evidence of biological activity in humans. In vitro and ex-vivo data suggest that a longterm presence of the drug in target tissues may provide antitumour activity.

The study investigates the safety and tolerability of different doses of Blinatumomab administration in a continuous infusion regimen. Maximum tolerated dose (MTD) will be defined in a classical 3+3 dose escalation regimen.

Safety Study of the Bispecific T-cell Engager Blinatumomab (MT103) in Patients With Relapsed NHL

An Open-label, Multi-center Phase I Study to Investigate the Tolerability and Safety of a Continuous Infusion of the Bispecific T-cell Engager MT103 in Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)

Participants reporting at least one occurence of any adverse event including clinical symptoms, laboratory abnormalities, serious adverse events, and treatment-limiting adverse events

The steady state serum concentration (Css), summarized as the observed concentrations collected at least 10 hours after the start of continuous intravenous infusion or within the sampling window at the end of infusion. Concentrations below the lower limit of quantitation (100 pg/mL) were excluded from analysis.

Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration).

Best clinical response is defined as the best response achieved during the course of the study, with response defined as: Complete Response, Complete Response Unconfirmed, Partial Response, Stable Disease, and Progressive Disease. In this analysis minimal response is set to stable disease as intended in the response categories according to the Cheson criteria. An independent external review by a radiologist (computed tomography scans) and a pathologist (biopsies) was performed to confirm response status.

If no post-baseline tumor assessment was available, the overall clinical response was set to not available.

Tumor response was defined according to the Cheson criteria and assessed after 4 and 8 weeks of study treatment using computed tomography (CT) scan (neck, thorax and abdomen/pelvic to assess nodal disease/organ enlargement due to nodal/diffuse infiltration), and bone marrow biopsy (to assess bone marrow infiltration). Minimal response was treated as a separate response category in this analysis. Best clinical response was defined as the best response achieved during the course of the study, whereby the following order was applied: Complete Response, Complete Response Unconfirmed, Partial Response, Minimal Response, Stable Disease, and Progressive Disease.

If no post-baseline tumor assessment was available, the overall clinical response was set to not available.

Amgen Research (Munich) GmbH

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

Summary of Adverse Events includes only those participants who received at least one dose of investigational product.

Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.

Blinatumomab ≤ 5 µg/m²/d

Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.

Blinatumomab 15 µg/m²/d

Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.

Blinatumomab 30 µg/m²/d

Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.

Blinatumomab 60 µg/m²/d Flat

Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.

Blinatumomab 60 µg/m²/d Step

Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.

Blinatumomab 90 µg/m²/d

All participants who received any dose of blinatumomab

Blinatumomab Overall

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Study Director

All participants who received at least one infusion of blinatumomab

Number of Participants With Adverse Events

Participants who received blinatumomab 5 µg/m²/day as continuous intravenous infusion in the first treatment cycle.

Blinatumomab 5 µg/m²/d

Participants who received blinatumomab 15 µg/m²/day as continuous intravenous infusion in the first treatment cyle.

Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion in hte first treatment cycle.

Participants received blinatumomab 60 µg/m²/day as continuous intravenous infusion in the first treatment cycle.

Blinatumomab 60 µg/m²/d

Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion in the first treatment cycle.

Participants who received blinatumomab and had available pharmacokinetic data

Serum Concentration of Blinatumomab

Complete response

Complete response unconfirmed

Partial response

Stable disease

Progressive disease

Not available

Objective Tumor Response According to the Cheson Criteria (Without Minimal Response)

Minimal response

Objective Tumor Response According to the Cheson Criteria (With Minimal Response)

Overall Study

Respiratory Tract (Lung and Bronchial) Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

AMG 757

Tarlatamab will be administered as a 60-minute intravenous infusion with 1 mg step dose on cycle 1 day 1 followed by a 10 mg target dose on cycle 1 day 8 and cycle 1 day 15 in a 28-day cycle. Subsequent doses (10 mg) will be administered every 2 weeks.

Tarlatamab

Amgen Call Center

The primary objective of the study is to provide expanded access to and characterize the safety profile of tarlatamab in participants with advanced small cell lung cancer (SCLC) after two or more prior lines of treatment (including at least one platinum-based regimen).

Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer

A Phase 3b, Multicenter, Single-arm, Expanded Access Protocol of Tarlatamab (AMG 757) for the Treatment of Subjects With Advanced Small Cell Lung Cancer After Two or More Prior Lines of Treatment

Amgen

Infections

Virus Diseases

Safety Run-In Phase: CF33-CD19 will be administered intratumorally on Days 1 and 8 of Cycle 1 and Day 1 of each subsequent 21-day cycle.

Dose Escalation Combination Phase: CF33-CD19 will be administered intratumorally on Days 1 and 15 of each 28-day cycle.

CF33-CD19 IT

Safety Run-In Phase: CF33-CD19 will be administered intravenously on Days 1 and 8 of Cycle 1 and Day 1 of each subsequent 21-day cycle.

Dose Escalation Combination Phase: CF33-CD19 will be administered intravenously on Days 1 and 15 of each 28-day cycle.

CF33-CD19 IV

Blinatumomab will be infused via a 7-day continuous infusion from Days 2-9 and Days 16-23 of each 28-day cycle.

Yuni Kim

Aruna Parikh

Dan Li, MD

Kayla Webb

Jennifer Leddon

Li Li

Anthony Conley

This is an open-label, dose escalation and dose expansion, multi-center phase I study evaluating the safety and tolerability of CF33-CD19 administered intravenously (IV) or intratumorally (IT) in combination with blinatumomab in adults with advanced or metastatic solid tumors.

CF33-CD19, a novel chimeric orthopoxvirus, will be administered as a monotherapy or in combination with blinatumomab to assess the safety and efficacy of the treatment regimens as well as immunological changes in the tumour microenvironment.

Subjects eligible for treatment include those with any metastatic or advanced solid tumor who have documented radiological progression per RECIST following at least two prior lines of therapy.

All enrolled monotherapy subjects will be treated with CF33-CD19 on Day 1 and 8 of Cycle 1 and then on Day 1 of each 21-day cycle thereafter. Subjects treated with the combination regimen will receive CF33-CD19 on Days 1 and 15 of each 28-day cycle. In addition, they will receive blinatumomab as a 7-day continuous infusion from Days 2-9 and Days 16-23 of each cycle.

A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)

A Phase I, Dose Escalation and Dose Expansion, Safety and Tolerability Study of onCARlytics (CF33-CD19), Administered Intravenously or Intratumorally in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)

Adverse events will be graded according to CTCAE v5.0.

Change in lymphocyte subset expression in tumor tissue and peripheral blood pre and post dose

Change in cytokine levels in peripheral blood pre and post dose

Stable Disease and Response (PR and CR) based on RECIST v1.1 and iRECIST v1.0.

Overall Response Rate (ORR) is defined as the proportion of subjects in the efficacy population who achieve a radiographic Investigator-assessed confirmed CR or PR, per RECIST v1.1 or confirmed iCR or iPR per iRECIST v1.0.

Progression Free Survival (PFS) defined as the time from first dose of study drug to first documentation of PD based on RECIST 1.1, or to death from any cause.

Duration of Response (DoR) measured as the time from the date a response of PR/iPR or better was first recorded to the date on which progressive disease was first noted or the date of death due to any cause.

Disease Control Rate (DCR), measured as the proportion of subjects who achieve an Investigator-assessed confirmed CR/iCR, PR/iPR, or Stable Disease (SD)/immune SD (iSD) per RECIST v1.1 and iRECIST v1.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Study of the Bispecific T-cell Engager Blinatumomab (MT103) in Patients With Relapsed NHL	NCT00274742	Non-Hodgkin's L...	Blinatumomab (M...	18 Years -	Amgen Research (Munich) GmbH
Tarlatamab (AMG 757) Expanded Access Protocol for Advanced Small Cell Lung Cancer	NCT06064500	Small Cell Lung...	Tarlatamab	18 Years -	Amgen
Safety Study of the Bispecific T-cell Engager Blinatumomab (MT103) in Patients With Relapsed NHL	NCT00274742	Non-Hodgkin's L...	Blinatumomab (M...	18 Years -	Amgen Research (Munich) GmbH
A Study of onCARlytics (CF33-CD19) in Combination With Blinatumomab in Adults With Advanced or Metastatic Solid Tumors (OASIS)	NCT06063317	Solid Tumor, Ad...	CF33-CD19 IT CF33-CD19 IV Blinatumomab	18 Years -	Imugene Limited

Spots Global Cancer Trial Database for bite

Every month we try and update this database with for bite 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 bite

Every month we try and update this database with for bite 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 bite 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.