Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

Inclusion Criteria

Subject has relapsed or refractory CD22-positive histologically confirmed NHL
An archival paraffin-embedded tissue or fresh biopsy is available for the retrospective quantitative assessment of CD22 levels
Bone marrow involvement of cellular marrow with lymphoma determined to be < 25%
Subject has failed at least one prior chemo-/immunotherapy-based regimen
Life expectancy of at least 12 weeks
Not eligible for, or refused, or failed high-dose therapy combined with autologous stem cell rescue (HDT ASCR)
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
Women of childbearing potential must have negative pregnancy test within seven days before the start of treatment
Subject was using adequate barrier birth control measures before the study and is willing to continue use of these during the entire course of the study and for the twelve months after the last administration of BAY1862864 Injection
Adequate bone-marrow, hepatic and renal function
Subject is capable of giving informed consent and has provided such consent in writing

Exclusion Criteria

Previous exposure to the study drug. Previous exposure to CD22 antibody within six months before screening. Any radio-immunotherapy within six months before screening.
History of anaphylactic reactions to monoclonal antibody therapy. Known or suspected allergy or intolerance to any agent to be given in the course of this study.
Anti-cancer immunotherapy and/or anti cancer chemotherapy within four weeks before the first dose of study drug
Previous therapy with fludarabine-containing regimens within three months before screening
Participation in any other clinical trial in which the subject received active therapy within four weeks before the first scheduled dose of study drug
Any toxic effects (CTCAE ≥ Grade 2) of previous anti cancer therapy (incl. radiotherapy) that have not yet stabilized or significant post-treatment toxicities have been observed
Prior definitive radiotherapy completed less than four weeks before the date scheduled for first dose of BAY1862864
History of symptomatic metastatic brain or meningeal tumors. Presence of new or progressive brain metastases.
History of clinically significant cardiac disease
Clinically relevant findings in the ECG.
Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg and / or diastolic blood pressure > 100 mmHg, despite optimum medical management
History of arterial or venous thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or clinically relevant pulmonary embolism within three months before the first administration of BAY1862864 (except for adequately treated catheter-related venous thrombosis occurring more than one month before start of study medication)
Autologous bone-marrow transplant or stem-cell rescue within three months before the first administration of BAY1862864
Organ allograft (except for corneal transplant) or allogeneic bone-marrow transplant at any time before the first administration of BAY1862864
Positive result of hepatitis B virus (HBV-DNA) and/or human immunodeficiency virus antibody (HIV-Ab) test
Liver cirrhosis, defined as Child-Pugh class B or C
Any active infection of CTCAE Grade ≥2
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study
Major surgery or significant trauma within four weeks before the first administration of BAY1862864
Any treatment with biological response modifiers (such as, but not limited to, granulocyte colony-stimulating factor, G CSF), or any blood transfusion, within three weeks before first administration of BAY1862864
Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study result
Current pregnancy or breast-feeding
Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance with study requirements
Close affiliation with the investigation site
Any use by the subject of illicit drugs or other substances that may, in the opinion of the investigator or his/her designated associate(s), have a reasonable chance of contributing to toxicity or otherwise confound the results

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 1b	BAY1862864	Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 1.5 MBq (10 mg ACC).
Cohort 2	BAY1862864	Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 3.1 MBq (10 mg ACC).
Cohort 1a	BAY1862864	Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 1.5 MBq (2 mg antibody chelator conjugate \[ACC\]).
Cohort 3	BAY1862864	Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 4.6 MBq (10 mg ACC).
Cohort 4	BAY1862864	Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 6.1 MBq (10 mg ACC).

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs)	Up to 6 weeks

Secondary Outcome Measures

Name	Time	Method

Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma

Recruitment & Eligibility

Study & Design

Trial Locations

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