Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With R/R B-NHL

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    73
  • sponsor
    Genmab
Updated on 24 May 2021
Investigator
Genmab A/S Trial Information
Primary Contact
Osaka University Hospital (4.1 mi away) Contact
+20 other location
ct scan
lymphoma
monoclonal antibodies
measurable disease
follicular lymphoma
monoclonal protein
diffuse large b-cell lymphoma
b-cell lymphoma
antineoplastic
marginal zone lymphoma
large b-cell lymphoma

Summary

The purpose of the trial is to determine the maximum tolerated dose and/or the recommended phase 2 dose as well as to establish the safety profile of epcoritamab in Japanese patients with Relapsed, Progressive or Refractory B-Cell Lymphomas.

Description

The trial is an open-label, multi-center safety trial of epcoritamab. The trial consists of two parts: Part 1, dose escalation (phase 1), and Part 2, expansion (phase 2). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined in Part 1.

Details
Condition Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Lymphoma, MALT Lymphoma, Chronic Lymphocytic Leukemia, Lymphocytic Leukemia, Chronic, Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma, Primary Mediastinal Large B Cell Lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma, leukemia chronic lymphocytic, chronic lymphocytic leukemia (cll), small lymphocytic lymphoma, diffuse large cell lymphoma, diffuse large b cell lymphoma, b-cell small lymphocytic lymphoma, High-grade B-cell Lymphoma, High-grade B-cell Lymphoma
Treatment Epcoritamab
Clinical Study IdentifierNCT04542824
SponsorGenmab
Last Modified on24 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must be at least 20 years of age, inclusive
Japanese subjects
Documented CD20 positive mature B-cell neoplasm
Part 1 - dose escalation
Diffuse large B-cell lymphoma (de novo or histologically transformed)
High-grade B-cell lymphoma
Primary mediastinal large B-cell lymphoma
Follicular lymphoma
Marginal zone lymphoma (nodal, extranodal of mucosa-associated lymphoid tissue, or splenic)
Small lymphocytic lymphoma 2. Part 2 - expansion
Diffuse large B-cell lymphoma (de novo or histologically transformed)
Follicular lymphoma grade 1-3A
Relapsed or refractory disease and previously treated with at least 2 lines of systemic antineoplastic therapy including at least 1 anti-CD20 mAb-containing therapy
Measurable disease by CT, MRI or PET-CT scan

Exclusion Criteria

Primary CNS lymphoma or CNS involvement by lymphoma
Subjects not eligible for high dose therapy with autologous hematopoietic stem cell transplantation due to personal choice, social issues, or similar
AST and/or ALT > 3 xULN
Total bilirubin > 1.5 xULN (unless due to Gilbert syndrome)
Creatinine clearance < 45 mL/min
Known clinically significant cardiac disease
Chronic ongoing infectious diseases requiring treatment (excluding prophylactic treatment)
Exposed to live or live attenuated vaccine within 4 weeks before the first dose of epcoritamab
Active hepatitis B (HepB DNA positive) or hepatitis C (HepC RNA positive)
Known history or positive test results confirming HIV infection
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note