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Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

RECRUITINGPhase 1Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Actively Recruiting
PhasePhase 1
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Started2025-07-18
Est. completion2027-07-01
Eligibility
Age18 Years – 100 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06676033

Summary

This correlative study aims to understand the pharmacodynamic effects and clonal dynamics in response to epcoritamab by obtaining and analyzing lymph node, bone marrow, and blood samples from subjects enrolled in GCT3013-03 trial sponsored by Genmab at NIH. Samples will be collected before and at multiple time points during treatment with epcoritamab. National Heart, Lung, and Blood Institute (NHLBI) investigators are experienced in testing samples treated with bsAb2,3 including epcoritamab in an ongoing pre-clinical collaboration with Genmab. Addressing the objectives of this correlative study will advance the science and clinical application of epcoritamab specifically as well as T-cell engaging bsAb in general as an emerging class of immunotherapy for cancer. The study is enrolling by invitation only.

Eligibility

Age: 18 Years – 100 YearsHealthy volunteers accepted
* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Must be undergoing screening for GCT3013-03
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Ability of subject to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

None

Conditions2

Leukemia, Chronic LymphocyticRichter Syndrome

Locations1 site

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR)800-411-1222ccopr@nih.gov

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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