Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma
An Open-label Phase I, Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Biodistribution, Radiation Dosimetry and Pharmacokinetics of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma
2 other identifiers
interventional
21
2 countries
4
Brief Summary
To establish a recommended dose of BAY1862864 Injection and to investigate how the study drug acts in the body, on the cancer cells and how safe it is in patients with advanced non-Hodgkin's lymphoma (NHL)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2015
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2015
CompletedFirst Posted
Study publicly available on registry
October 21, 2015
CompletedStudy Start
First participant enrolled
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2019
CompletedNovember 25, 2020
November 1, 2020
4 years
October 20, 2015
November 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs)
Up to 6 weeks
Study Arms (5)
Cohort 1a
EXPERIMENTALCancer 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 1b
EXPERIMENTALCancer 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
EXPERIMENTALCancer 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 3
EXPERIMENTALCancer 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
EXPERIMENTALCancer 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).
Interventions
Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (4)
Skanes Universitetssjukhus
Lund, 221 85, Sweden
Southampton General Hospital
Southampton, Hampshire, SO16 6YD, United Kingdom
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, SM2 5PT, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
Related Publications (1)
Linden O, Bates AT, Cunningham D, Hindorf C, Larsson E, Cleton A, Pinkert J, Huang F, Bladt F, Hennekes H, Oedegaardstuen LI, Sturm I, McNamara C. 227Th-Labeled Anti-CD22 Antibody (BAY 1862864) in Relapsed/Refractory CD22-Positive Non-Hodgkin Lymphoma: A First-in-Human, Phase I Study. Cancer Biother Radiopharm. 2021 Oct;36(8):672-681. doi: 10.1089/cbr.2020.4653. Epub 2021 Apr 21.
PMID: 33887152DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2015
First Posted
October 21, 2015
Study Start
November 20, 2015
Primary Completion
November 11, 2019
Study Completion
November 26, 2019
Last Updated
November 25, 2020
Record last verified: 2020-11