iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL.
Michael Hallek, Bruce D Cheson, Daniel Catovsky...
https://pubmed.ncbi.nlm.nih.gov/29540348Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID04704323
An Open Label Phase Ia/b Dose Escalation and Expansion Trial of CAP-100, a Humanized CCR7 Antibody, in Relapsed/Refractory Chronic Lymphocytic Leukemia
Led by Catapult Therapeutics · Updated on 2025-07-17
18
Participants Needed
4
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating CAP-100, a humanized antibody targeting C-C-chemokine receptor 7 (CCR7), in people with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Current treatments include targeted therapies and immuno-chemotherapy, but new options are needed for patients who cannot use or do not respond to these treatments. CAP-100 is designed to stop leukemia cells from surviving in lymphoid areas and to eliminate CCR7-positive leukemia cells, potentially leading to clinical responses. The trial has two parts: Phase Ia (dose escalation) and Phase Ib (dose expansion). In Phase Ia, small groups of participants receive increasing intravenous doses of CAP-100 to determine the recommended dose for Phase II. In Phase Ib, additional participants receive CAP-100 at the recommended dose to evaluate safety and early signs of benefit, including response rate, lymph node size reduction, and minimal residual disease assessment. Participants will undergo safety monitoring for treatment-related side effects during and after dosing. Researchers will measure clinical responses over three cycles (84 days) to assess preliminary benefits. The study involves regular assessments including blood tests and imaging to monitor disease status and side effects. The trial aims to establish the proper dose and gather initial safety and effectiveness data to guide future studies.
CONDITIONS
Brief Title
CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able to understand and sign a written informed consent document
- ECOG performance status of 0, 1, or 2
- Relapsed or refractory to at least two prior standard systemic treatments for CLL or SLL
- Prior therapy discontinued for at least five times its half-life; major surgery or irradiation completed more than 4 weeks before trial
- Life expectancy greater than 16 weeks
- Diagnosis of CLL or SLL according to guidelines
- Active disease per iwCLL 2018 criteria
- Platelet count at least 50,000/µL unless due to bone marrow infiltration
- Adequate liver function as specified
- Creatinine clearance at least 45 mL/min/1.73m2
- Use of effective contraception during and 4 months after treatment for those of childbearing potential
You will not qualify if you...
- Allogeneic stem-cell transplant within 6 months prior to trial
- Monoclonal antibody cancer therapy within 4 weeks prior to trial
- Unresolved side effects from prior therapy above Grade 1
- Use of certain oral targeted inhibitors within five times their half-life
- Active viral, bacterial, or systemic fungal infection requiring treatment
- Known HIV-positive status
- Active central nervous system lymphoma
- Pregnant or breastfeeding women
- History of cancer within 2 years except certain controlled cancers
- Uncontrolled heart conditions, recent heart attack, severe arrhythmias, or unstable angina
- Brain metastasis or psychiatric illness limiting compliance
- Known hypersensitivity to drug components
- History of human anti-globulin antibodies
- Active autoimmune disease or autoimmune-related neurological disorders
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 3 cycles (84 days)
Participants receive intravenous administrations of CAP-100, a humanized antibody targeting CCR7, in escalating doses or at the recommended phase 2 dose depending on their cohort.
Multiple visits for dosing and assessments during each cycle
Trial Site Locations
Total: 4 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
3
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Actively Recruiting
4
Hospital Universitario Marqués de Valdecilla
Santander, Spain, 39008
Actively Recruiting
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Research Team
M
Marlies Van Hoef, MD, PhD, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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