Epcoritamab in Chronic Lymphocytic Leukemia and Richter Syndrome

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Study ID
NCT06676033
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Leukemia, Chronic Lymphocytic
  • Richter Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • epcoritamab — DRUG
    Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.

Study Details

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.

Key Dates

Start date
Jul 18, 2025
Status verified
Feb 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: epcoritamab
    Samples from subjects receiving epcoritamab on another clinical trial GCT3013-03 will be collected.

Primary Outcome Measure

Immunophenotype and transcriptome of T cells and tumor cells in lymph node and bone marrow [ Time Frame: 25 days (Cycle 1 Day 25) ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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National Institutes of Health Clinical Center· Bethesda, MD

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