Epcoritamab treatment for chronic lymphocytic leukemia and Richter syndrome
Correlative Study of Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome
This study is testing if a new treatment called epcoritamab can help people with chronic lymphocytic leukemia and Richter syndrome by looking at how it affects their blood and lymph nodes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | epcoritamab, Genmab, immunotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06676033 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of epcoritamab on chronic lymphocytic leukemia (CLL) and Richter syndrome by analyzing lymph node, bone marrow, and blood samples from participants. Patients enrolled in a related trial will undergo various procedures, including biopsies and blood draws, to evaluate the pharmacodynamic effects of the treatment. The study aims to assess how epcoritamab influences the tumor microenvironment and clonal dynamics, with a focus on identifying biomarkers that could enhance treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates are individuals currently undergoing screening for the related GCT3013-03 trial and willing to comply with study procedures.
Not a fit: Patients not enrolled in the GCT3013-03 trial will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with chronic lymphocytic leukemia and Richter syndrome.
How similar studies have performed: Other studies involving T-cell engaging bispecific antibodies have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Clare C Sun, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Ingrid C Frey
- Email: ingrid.frey@nih.gov
- Phone: (301) 312-0765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.