Lymphocytic Leukemia, ChronicPhase 1NCT04704323
CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
A Phase 1 study testing CAP-100 in people with Lymphocytic Leukemia, Chronic and SLL, run by Catapult Therapeutics at 4 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphocytic Leukemia, Chronic, SLL
- What is being tested?
- CAP-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 10 Sep 2021to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Able to understand and sign a written informed consent document.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL (USA).
- Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL and without available therapies known to provide clinical benefit (until new amendment implemented, Spain).
- Prior CLL or SLL systemic therapy must have been discontinued for a duration of at least five times its half-life (palliative low dose steroids are allowed to bridge the time to CAP-100; major surgery or irradiation for CLL must have been completed > 4 weeks prior to the first trial dose of medication). Prior chimeric antigen receptor (CAR)-T cell therapy is allowed.
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- Life expectancy > 16 weeks.
- Subjects must have met the diagnostic criteria for CLL according to the iwCLL 2018 guidelines (Hallek et al, 2018) or for SLL (NCCN guidelines, 2020) at some point during their disease course.
- Subjects must meet iwCLL 2018 guideline criteria (Hallek et al, 2018) for active disease.
- Platelet count ≥ 50,000/ μL, unless decrease is attributable to bone marrow infiltration of CLL.
- Adequate liver function as indicated by aspartate transaminase (AST)/ alanine transaminase (ALT) ≤ 2.5 times upper limit of normal (ULN), unless directly attributable to the subject's tumor (in this case, acceptable levels are ≤ 5 x ULN).
- Renal function as defined by creatinine clearance (CrCl)≥ 45 mL/min/1.73m2 (by CKD-EPI formula).
- Women of childbearing potential and male subjects who have partners capable of reproduction must agree to use an effective contraceptive method during the course of the trial and for 4 months following the completion of their last treatment. Women of childbearing potential must have a negative serum β-subunit of hCG gonadotropin (β-hCG) pregnancy test result within 7 days of first trial dose. Female subjects who are surgically sterilized or who are > 45 years old and have not experienced menses for > 2 years may have β-hCG pregnancy test waived.
Who cannot join
- Allogeneic stem-cell transplantation within 6 months of trial entry.
- Monoclonal antibody for anti-cancer therapy within 4 weeks of trial entry.
- Side effects due to prior therapy not recovered to ≤Grade 1.
- Oral targeted inhibitors (Bruton's tyrosine kinase [BTK]-inhibitors, B-cell lymphoma 2 [BCL-2] inhibitors, phosphoinositide 3-kinase [PI3K] inhibitors) within five times their half-life.
- Active viral, bacterial or systemic fungal infection requiring treatment.
- Subjects who are known to be human immunodeficiency virus (HIV)-positive.
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- Subjects with active known central nervous system (CNS) lymphoma.
- Pregnant or lactating women.
- History of previous cancer < 2 years before the trial, except controlled disease using systemic therapy with curative intent, surgical therapy with curative intent or skin cancer, cancer in situ, and prostate cancer on the "watch and wait" approach.
- Uncontrolled intercurrent illness including, but not limited to, New York Heart Association Class (NYHA) III and IV congestive heart failure, myocardial infraction within the previous 6 months, ejection fraction (EF) < 40%, life-threatening arrhythmias, or unstable angina brain metastasis or psychiatric illness that would limit compliance with trial requirement.
- Subjects with known hypersensitivity to any excipient contained in the drug formulation.
- Subjects with a history of documented human anti-globulin antibodies.
- Active autoimmune disease, motor neuropathy considered of autoimmune origin, and other CNS autoimmune disease.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States2 sites, 2 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Sobana Balasubramanian, 857-215-1681, SobanaJ_Balasubramanian@DFCI.HARVARD.EDU
Jennifer Brown
- Recruiting
Duke University
Durham, North Carolina, 27705
Terri Lucas, +1 919 681 6580, terri.lucas@duke.edu
Danielle Brander, MD
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de La Princesa
Madrid, 28006
Carmen Montes, 34915202316, cm.jimenez.hematologia@gmail.co
Javier Loscertales
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Alba del Rio Manzano, 34 942315275, amanzano@idival.org
Lucrecia Yáñez San Segundo
About this study
Official title: An Open Label Phase Ia/b Dose Escalation Followed by Dose Expansion Safety and Tolerability Trial of CAP-100, a Humanized C-C-chemokine Receptor 7 Antibody, Administered as Monotherapy in Subjects With r/r Chronic Lymphocytic Leukemia
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.
Read more
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 evaluate the safety and preliminary clinical benefit of CAP-100 monotherapy at RP2D (response rate, lymph node size reduction, assessment of minimal residual disease [MRD]) to support the design of future trials investigating CAP-100 either as monotherapy or in a combination setting with approved treatments for CLL.
- Conditions
- Lymphocytic Leukemia, Chronic, SLL
- Being tested
- CAP-100
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAP-100Drug
CAP-100 (humanized antibody against C-C-chemokine receptor 7 [CCR]7)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Phase Ia - Dose escalation | Experimental | Cohorts of 3 subjects (last cohort 6 subjects) will receive intravenous [IV] administrations of escalating doses of CAP-100. Receives: Drug: CAP-100 |
| Experimental: Phase Ib - Dose expansion | Experimental | Ten subjects will receive intravenous [IV] administrations of CAP-100 at the Recommended Phase 2 Dose determined in Phase Ia - Dose Escalation of this trial. Receives: Drug: CAP-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse effects at increasing doses of CAP-100 (safety and tolerability)
The incidence of Grade 3 and Grade 4 AEs related to CAP-100 administration according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 for non-hematological AEs.
The incidence and severity of hematological AEs related to CAP-100 treatment according to CLL international working group criteria (iwCLL, Hallek et al, 2018).
Measured: 28 Days
Incidence of treatment emergent adverse effects of CAP-100 at RP2D in an expanded cohort (safety and tolerability)
The incidence of Grade 3 and Grade 4 AEs related to CAP-100 administration according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 for non-hematological AEs.
The incidence and severity of hematological AEs related to CAP-100 treatment according to CLL international working group criteria (iwCLL, Hallek et al, 2018).
Measured: 28 Days
Preliminary clinical benefit of CAP-100 monotherapy at RP2D
Overall response rate (ORR) after 3 cycles of CAP-100 treatment according to iwCLL criteria
Measured: 3 Cycles (84 Days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start10 Sep 2021
- Primary completionJan 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphocytic Leukemia, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catapult Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704323
- Sponsor's protocol ID
- CAP-100-1
- Status last verified
- Jul 2025
- First submitted
- 21 Dec 2020
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H, Hillmen P, Keating M, Montserrat E, Chiorazzi N, Stilgenbauer S, Rai KR, Byrd JC, Eichhorst B, O'Brien S, Robak T, Seymour JF, Kipps TJ. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018 Jun 21;131(25):2745-2760. doi: 10.1182/blood-2017-09-806398. Epub 2018 Mar 14.
PubMed 29540348
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase Ia/b Dose Escalation Followed by Dose Expansion Safety and Tolerability Trial of CAP-100, a Humanized C-C-chemokine Receptor 7 Antibody, Administered as Monotherapy in Subjects With r/r Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT04704323
- Acronym / sponsor ID
- CAP-100-1
- Conditions
- Lymphocytic Leukemia, Chronic, SLL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Catapult TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 evaluate the safety and preliminary clinical benefit of CAP-100 monotherapy at RP2D (response rate, lymph node size reduction, assessment of minimal residual disease [MRD]) to support the design of future trials investigating CAP-100 either as monotherapy or in a combination setting with approved treatments for CLL.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Phase Ia - Dose escalation | Experimental | Drug: CAP-100Cohorts of 3 subjects (last cohort 6 subjects) will receive intravenous [IV] administrations of escalating doses of CAP-100. |
| Experimental: Phase Ib - Dose expansion | Experimental | Drug: CAP-100Ten subjects will receive intravenous [IV] administrations of CAP-100 at the Recommended Phase 2 Dose determined in Phase Ia - Dose Escalation of this trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years.
- Able to understand and sign a written informed consent document.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL (USA).
- Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL and without available therapies known to provide clinical benefit (until new amendment implemented, Spain).
Key exclusion criteria (13 listed)
- Allogeneic stem-cell transplantation within 6 months of trial entry.
- Monoclonal antibody for anti-cancer therapy within 4 weeks of trial entry.
- Side effects due to prior therapy not recovered to ≤Grade 1.
- Oral targeted inhibitors (Bruton's tyrosine kinase [BTK]-inhibitors, B-cell lymphoma 2 [BCL-2] inhibitors, phosphoinositide 3-kinase [PI3K] inhibitors) within five times their half-life.
- Active viral, bacterial or systemic fungal infection requiring treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAP-100CAP-100 (humanized antibody against C-C-chemokine receptor 7 [CCR]7) | Drug | Experimental: Phase Ia - Dose escalation, Experimental: Phase Ib - Dose expansion |
Primary outcome
Incidence of treatment emergent adverse effects at increasing doses of CAP-100 (safety and tolerability)
Time frame: 28 Days
The incidence of Grade 3 and Grade 4 AEs related to CAP-100 administration according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 for non-hematological AEs. The incidence and severity of hematological AEs related to CAP-100 treatment according to CLL international working group criteria (iwCLL, Hallek et al, 2018).
Incidence of treatment emergent adverse effects of CAP-100 at RP2D in an expanded cohort (safety and tolerability)
Time frame: 28 Days
The incidence of Grade 3 and Grade 4 AEs related to CAP-100 administration according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 for non-hematological AEs. The incidence and severity of hematological AEs related to CAP-100 treatment according to CLL international working group criteria (iwCLL, Hallek et al, 2018).
Preliminary clinical benefit of CAP-100 monotherapy at RP2D
Time frame: 3 Cycles (84 Days)
Overall response rate (ORR) after 3 cycles of CAP-100 treatment according to iwCLL criteria
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Background: PubMed 29540348Hallek M, Cheson BD, Catovsky D, Caligaris-Cappio F, Dighiero G, Dohner H, Hillmen P, Keating M, Montserrat E, Chiorazzi N, Stilgenbauer S, Rai KR, Byrd JC, Eichhorst B, O'Brien S, Robak T, Seymour JF, Kipps TJ. iwCLL guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL. Blood. 2018 Jun 21;131(25):2745-2760. doi: 10.1182/blood-2017-09-806398. Epub 2018 Mar 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAP-100 in people with Lymphocytic Leukemia, Chronic and SLL, run by Catapult Therapeutics at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marlies Van Hoef, MD, PhD, MBA (+31612433616, m.vanhoef@catapult-therapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment emergent adverse effects at increasing doses of CAP-100 (safety and tolerability) (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04704323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.