Protocol Details

Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	001671-H
Sponsoring Institute	National Heart, Lung and Blood Institute (NHLBI)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 100 Years
Referral Letter Required	Yes
Population Exclusion(s)	Children
Keywords	Epcoritamab, Pharmacodynamic, Tumor Microenvironment, Clonal Dynamics, Biomarker
Recruitment Keyword(s)	None
Condition(s)	Leukemia, Chronic Lymphocytic; Richter Syndrome
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	Drug: epcoritamab
Supporting Site	National Heart, Lung, and Blood Institute

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.

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Eligibility

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

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Citations:

Not Provided

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Contacts:

Principal Investigator	Referral Contact	For more information:
Clare C. Sun, M.D. National Heart, Lung and Blood Institute (NHLBI) NIHBC 10 - CRC BG RM 3-5132 10 CENTER DR BETHESDA MD 20892 (301) 402-1806 clare.sun@nih.gov	Ingrid C. Frey National Heart, Lung and Blood Institute (NHLBI) BG 10-CRC RM 5-1424 10 CENTER DR BETHESDA MD 20814 (301) 312-0765 ingrid.frey@nih.gov	Office of Patient Recruitment National Institutes of Health Clinical Center (CC) Building 61, 10 Cloister Court Bethesda, Maryland 20892 Toll Free: 1-800-411-1222 Local Phone: 301-451-4383 TTY: TTY Users Dial 7-1-1 ccopr@nih.gov

Clinical Trials Number:

NCT06676033

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