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

NCT02106091 | Terminated Phase 1 DMC

• 2 other identifiers: AFM11-1012013-001919-78
• Study Type: interventional
• Target: 16
• Locations: 4 countries
• Sites: 9

Brief 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).

Conditions

Relapsed B-Cell Non-Hodgkin Lymphoma; Refractory B-Cell Non-Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with serious and non-serious adverse events as a measure of safety and tolerability of AFM11.

  Measure occurence of adverse events until the Final Study Visit and monitor laboratory safety parameters at least once weekly. Assess immunogenicity of AFM11 at end of treatment cycle.

  From administration of the first dose of study drug and through 30 days after the last dose, up to 8 weeks.

Secondary Outcomes (3)

• Maximum Tolerated Dose (MTD) of AFM11.

  up to 8 weeks

• Pharmacokinetic profile of AFM11 and immunological markers of AFM11 activity.

  Prior to initial dose on Day 1 and at multiple time points during the 4 weeks of treatment until up to 30 days after the last dose.

• Tumor Response.

  Baseline and at week 6.

Study Arms (1)

AFM11

EXPERIMENTAL

IV (intravenous) infusion, dose escalation

Drug: AFM11

Interventions

AFM11 DRUG

Accelerated-titration dose-escalation with 1 patient per dose-level, followed by standard dose-escalation (3 + 3 design), Treatment duration: 4 weeks.

AFM11

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Peripheral lymphocyte count \> 20 × 10\^9/L
• Platelet count ≤ 75,000/µL
• Hemoglobin level ≤ 9 g/dL.
• Known or suspected central nervous system (CNS) involvement.
• History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, and/or psychosis.
• Evidence for presence of malignant disease, inflammatory lesions, and/or vasculitis on cerebral MRI.
• Infiltration of the cerebrospinal fluid by malignant B-cells, confirmed by lumbar puncture.
• Cancer chemotherapy within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-lives, whichever is longer.
• Radiotherapy within 4 weeks prior to start of AFM11 treatment.
• Therapy with antibody, or antibody constructs within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-lives, whichever is longer.
• Prior treatment with alemtuzumab (Campath®) within 12 weeks prior to start of AFM11 treatment.
• Treatment with any investigational agent within 4 weeks prior to start of AFM11 treatment, or at least 4 times the respective half-life, whichever is longer.

Sponsors & Collaborators

• Affimed GmbH: lead

Study Sites (9)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Charles Hospital Prague

Prague, 11636, Czechia

Location

University Hospital of the Saarland

Homburg/Saar, 66421, Germany

Location

University Hospital

Kiel, 24105, Germany

Location

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, 55131, Germany

Location

University Hospital

Ulm, 89081, Germany

Location

University Hospital

Würzburg, 97080, Germany

Location

SP ZOZ University Hospital Krakow

Krakow, 31501, Poland

Location

MTZ Clinical Research

Warsaw, 02106, Poland

Location

Related Publications (1)

• Topp M, Dlugosz-Danecka M, Skotnicki AB, Salogub G, Viardot A, Klein AK, Hess G, Michel CS, Grosicki S, Gural A, Schwarz SE, Pietzko K, Gartner U, Strassz A, Alland L, Mayer J. Safety of AFM11 in the treatment of patients with B-cell malignancies: findings from two phase 1 studies. Trials. 2023 Jan 3;24(1):4. doi: 10.1186/s13063-022-06982-7.

  PMID: 36597128 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 8, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: June 18, 2019

Record last verified: 2019-05

Locations

DE (5); US (1); PL (2); CZ (1)