Loading clinical trials...

TERMINATEDPHASE1

Safety Study to Assess AFM11 in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL

A Pharmacodynamically-guided, Dose-escalation, Phase I Study to Assess the Safety of AFM11 (Recombinant Antibody Construct Against Human CD19 and CD3) in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL.

NCT02106091•Affimed GmbH

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether AFM11 is safe and active in the treatment of relapsed and/or refractory Non-Hodgkin Lymphoma (NHL).

Detailed Description

CD19 is present on B-cells from earliest recognizable B-lineage cells during development to B-cell blasts and is lost only upon maturation to plasma cells. Expression of CD19 on B-cells at various development stages makes it an ideal target to treat B-cell associated malignancies.The rationale for the use of AFM11 is based on its ability to bind to both malignant cells via its anti-CD19 domain and to T-cells via its anti-CD3 domains. This results in the formation of the "immunological synapse" and the subsequent T-cell activation on leading to killing of malignant cells.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with CD19+, relapsed or refractory histologically (WHO classification) confirmed follicular lymphoma, marginal zone lymphoma, lymphoplasmocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma, mediastinal B-cell lymphoma, or transformed B-cell lymphomas.
•Patients with either indolent or aggressive NHL.
•Patients who relapsed or were refractory to the approved standard therapy, which must have included 1 treatment line with rituximab plus chemotherapy, and who are not candidates for bone marrow transplant (including both peripheral blood and hematopoietic stem cell transplants with a curative intent.
•Measurable disease (at least 1 lesion ≥ 1.5 cm) documented by CT scan.
•Disease progression requiring therapy.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
•Life expectancy of at least 6 months.
•Ability to understand the patient information and informed consent form.
•Signed and written informed consent

Exclusion Criteria

•Total number of B-cells (healthy and malignant combined) in the peripheral blood exceeds the upper physiological limit (as per institutional guidance) of total B-cell counts in healthy individuals.
•Autologous Hematopoietic stem cell transplant (HSCT) within 12 weeks prior to start of AFM11 treatment.
•Abnormal hematological laboratory values as defined below:
•1. Peripheral lymphocyte count \> 20 × 10\^9/L
•2. Platelet count ≤ 75,000/µL
•3. Hemoglobin level ≤ 9 g/dL.
•Known or suspected central nervous system (CNS) involvement.
•1. History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, and/or psychosis.
•2. Evidence for presence of malignant disease, inflammatory lesions, and/or vasculitis on cerebral MRI.
•3. Infiltration of the cerebrospinal fluid by malignant B-cells, confirmed by lumbar puncture.
+16 more criteria

Locations (9)

Tufts Medical Center

Boston, Massachusetts, United States

Charles Hospital Prague

Prague, Czechia

University Hospital of the Saarland

Homburg/Saar, Germany

University Hospital

Kiel, Germany

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Germany

University Hospital

Ulm, Germany

University Hospital

Würzburg, Germany

SP ZOZ University Hospital Krakow

Krakow, Poland

MTZ Clinical Research

Warsaw, Poland

Key Dates

Start Date

April 1, 2014

Primary Completion Date

August 1, 2018

Completion Date

September 1, 2018

Last Updated

June 18, 2019

Enrollment

ACTUAL participants

Conditions

Relapsed B-Cell Non-Hodgkin LymphomaRefractory B-Cell Non-Hodgkin Lymphoma

Interventions

AFM11

DRUG

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

NCT06189391

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

View study

ACTIVE_NOT_RECRUITINGPHASE1

An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment

NCT04447716

Recurrent B-Cell Non-Hodgkin LymphomaRecurrent Follicular Lymphoma+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety Study to Assess AFM11 in Patients With Relapsed and/or Refractory CD19 Positive B-cell NHL

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate MK-1045 (CN201) in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (MK-1045-001/CN201-101)

An Early Phase Study of Venetoclax, Lenalidomide, and Rituximab/Hyaluronidase in Slow-Growing Lymphomas That Have Come Back After Treatment or Have Not Responded to Treatment

R-ICE and Lenalidomide in Treating Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma

A Study to Evaluate the Safety and Preliminary Efficacy of ATA3219 in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma

Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma