OncoMatch/Clinical Trials/NCT04704323
CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
Is NCT04704323 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CAP-100 for lymphocytic leukemia, chronic.
Treatment: CAP-100 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — CLL or SLL
Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL
Cannot have received: allogeneic stem cell transplant
Allogeneic stem-cell transplantation within 6 months of trial entry
Cannot have received: monoclonal antibody
Monoclonal antibody for anti-cancer therapy within 4 weeks of trial entry
Cannot have received: oral targeted inhibitor (BTK inhibitor, BCL2 inhibitor, PI3K inhibitor)
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
Lab requirements
Blood counts
Platelet count ≥ 50,000/ μL, unless decrease is attributable to bone marrow infiltration of CLL
Kidney function
creatinine clearance (CrCl)≥ 45 mL/min/1.73m2 (by CKD-EPI formula)
Liver function
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)
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).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Duke University · Durham, North Carolina
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