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Lymphoma, Non-HodgkinPhase 1NCT02581878

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

A Phase 1 study testing BAY1862864 in people with Lymphoma, Non-Hodgkin, run by Bayer at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Non-Hodgkin
What is being tested?
BAY1862864
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
4 sitesin 2 countries
Study dates
20 Nov 2015to 26 Nov 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United Kingdom3 sites

  • Royal Free Hospital

    London, NW3 2QG

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

  • Royal Marsden NHS Trust (Surrey)

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Sweden1 site

  • Skanes Universitetssjukhus

    Lund, 221 85

Other trials in Sweden

About this study

Official title: 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

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)

Read the detailed description

The study will be divided into two parts: a "dose-escalation part" to evaluate safety profile and to explore the Maximum tolerated dose (MTD) and an "expansion part" to evaluate further the safety and tumor response profile of BAY1862864 Injection at the selected dose.

Being tested
BAY1862864
Keywords
Thorium-227, BAY1862864 Injection, Safety, Pharmacokinetics, CD22, Radioimmunotherapy
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY1862864Drug

    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.

Study groups in NCT02581878
Study groupRoleWhat they receive
Cohort 1aExperimentalCancer 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]).
Receives: Drug: BAY1862864
Cohort 1bExperimentalCancer 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).
Receives: Drug: BAY1862864
Cohort 2ExperimentalCancer 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).
Receives: Drug: BAY1862864
Cohort 3ExperimentalCancer 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).
Receives: Drug: BAY1862864
Cohort 4ExperimentalCancer 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).
Receives: Drug: BAY1862864

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs)

    Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2015 (estimated)
  2. Study start20 Nov 2015
  3. Primary completion11 Nov 2019
  4. Study completion26 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02581878
Sponsor's protocol ID
17845
Other IDs
2014-004140-36, 2014
Status last verified
Nov 2020
First submitted
20 Oct 2015
Last updated
25 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 33887152

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BAY1862864 in people with Lymphoma, Non-Hodgkin, run by Bayer at 4 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United Kingdom, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs) (time frame: Up to 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02581878, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2020.

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