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Epcoritamab Compared to Observation for Treating B-cell Lymphoma Patients Not in Complete Remission

This study is looking at the efficacy of giving an investigational drug called Epcoritamab in comparison with no treatment after CAR-T treatment, in case there is partial remission. Standard practice is to observe the patients after CAR-T therapy. This study will investigate whether Epcoritamab is effective post CAR-T therapy when there is partial remission.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

The study involves study drug infusions or dosing, Medical history, Physical exam, weight, height, vital signs, and an assessment of daily activities, PET-CT scan for tumor assessment, Routine blood tests, Pregnancy test (if applicable), Routine and research blood sample collection, Research blood sample

Incentives

In-person visits:
1-40

Phone or online visits:
1-5

Total length of participation:
5 years

Looking for Specific Volunteers

Able to participate:

You have diffuse large b-cell lymphoma, primary mediastinal LBCL, follicular lymphoma 3B, or a transformation of an indolent lymphoma
You have been treated with CD19-directed CAR-T products and received a partial response to the treatment
You are willing to provide blood and tissue specimens

Not eligible if:

You have bulky and progressive disease after CAR-T treatment.
You achieved a complete response following CAR-T treatment
You are pregnant/nursing/planning to be pregnant
You have detectable Hepatitis B, Hepatitis C, or HIV.
You have other active malignancy that has required treatment less than 2 years prior to beginning this study

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Natalie Grover
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Glands and Hormones

IRB Number

24-1533

ClinicalTrials.gov

NCT06238648

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