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

Stopped early · Phase 1

Conditions studied: Relapsed B-Cell Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma

In brief

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).

Key facts

Study ID

NCT02106091

Run by

Affimed GmbH

People needed

16

Starts

2014-04-01

Expected to finish

2018-09-01

Last updated by the study team

2019-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Contraindication for any of the concomitant medications.
• Abnormal renal or hepatic function as follows: aspartate aminotransferase (AST or serum glutamic oxaloacetic transaminase [SGOT]) and/or alanine aminotransferase (ALT or serum glutamic pyruvic transaminase [SGPT]) ≥ 2.5 × upper limit of normal (ULN); total bilirubin ≥ 1.5 × ULN; serum creatinine ≥ 2 × ULN; creatinine clearance < 50 mL/minute.
• History of malignancy other than B-cell lymphoma within 5 years prior to study entry, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix.
• Active autoimmune disease requiring systemic immunosuppressive treatment.
• Uncontrolled infections; known bacteremia.
• Any concurrent disease or medical condition that is deemed to interfere with the conduct of the study as judged by the Investigator.
• Regular dose of corticosteroids during the 4 weeks prior to start of AFM11 treatment or anticipated need of continuous corticosteroids exceeding prednisone 20 mg/day or equivalent, or any other immunosuppressive therapy within 4 weeks prior to start of AFM11 treatment.
• Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B or hepatitis C virus.
• Pregnant or nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 12 weeks thereafter. Male patients not willing to ensure that during the study and at least 12 weeks thereafter no fathering takes place. Effective methods of contraception include intrauterine device 8(IUD), combined (estrogen- and progesterone-containing) hormonal contraception (oral, vaginal ring or transdermal patch) with an ethinylestradiol dose of at least 30 µg, plus use of male condoms (preferably with spermicides), female condoms, female diaphragm, or cervical cap.
• Prior treatment with blinatumomab or any other CD19 targeting T-cell engager, including CD19 CAR-T cells.

Where it is running

• 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

Full record on ClinicalTrials.gov

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