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Study identifier: NCT04704323 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia

Condition: Lymphocytic Leukemia, Chronic · SLL  ·  Sponsor: Catapult Therapeutics

PhasePhase 1
Planned participants18
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Introduction of immuno-chemotherapy in the treatment options of CLL and SLL changed the treatment paradigm of these diseases. Presently, first-line therapies for CLL/SLL include targeted therapies (e.g. ibrutinib, acalabrutinib) or combined immuno-chemotherapy regimens (e.g., fludarabine, cyclophosphamide, and rituximab for patients aged \<65 years without del17p/TP53 mutations or bendamustine and rituximab for patients ≥65 years who have additional comorbidities). Despite the gradual introduction of targeted therapies, new treatment strategies efficacious for patients ineligible for/unresponsive to these therapies are still required. These new strategies should ideally overcome disease relapse and circumvent compound-specific safety challenges. Emerging treatment options include new compounds aimed for both untreated and relapsed/refractory CLL, and combination therapies of existing compounds that extend single-agent efficacy in specific high-risk patient populations. CAP-100 is expected to prevent the migration of leukemia cells to and their survival in lymphoid niches as well as to eliminate CCR7-positive leukemia cells via ADCC, resulting in measurable clinical responses. The present trial is the first-in-human trial of CAP-100 and is divided into two phases. The aim of the Phase Ia (dose escalation) is to define the Recommended Phase 2 Dose (RP2D) versus the Maximum Tolerated Dose (MTD) of CAP-100 in subjects with CLL. Phase Ib of the trial (expansion phase) will eva…

This description comes directly from the study's public registry record.

Talk to the study team

Marlies Van Hoef, MD, PhD, MBA  ·  +31612433616  ·  m.vanhoef@catapult-therapeutics.com

Always discuss trial participation with your own doctor first.

Locations (4)

Dana-Farber Cancer InstituteBoston, Massachusetts, United StatesRecruiting
Duke UniversityDurham, North Carolina, United StatesRecruiting
Hospital Universitario de La PrincesaMadrid, SpainRecruiting
Hospital Universitario Marqués de ValdecillaSantander, SpainRecruiting

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Source record: clinicaltrials.gov/study/NCT04704323