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A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies
Trial Status: active
This clinical trial is evaluating a drug called AC676 in participants with
Relapsed/Refractory B-cell Malignancies. The main goals of the study are to:
- Identify the recommended dose of AC676 that can be given safely to participants
- Evaluate the safety profile of AC676
- Evaluate the pharmacokinetics of AC676
- Evaluate the effectiveness of AC676
Inclusion Criteria
Inclusion Criteria:
1. Adult male and female patients, at least 18 years-of-age at the time of signature of
the informed consent form (ICF).
2. Patients with histologically confirmed relapsed/refractory Chronic Lymphocytic
Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL),
Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), Marginal
Zone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).
3. Must have received at least 2 prior systemic therapies or have no other therapies to
provide significant clinical benefit in the opinion of the Investigator or who are
not amenable (intolerability, patient choice) to standard therapies.
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry:
1. Treatment with any of the following:
- Small molecule anti-cancer drugs within 5 half-lives or 2 days (whichever is
longer, not to exceed 14 days).
- Systemic chemotherapy within 14 days.
- Radiation therapy within 14 days
- Biologics (Antibodies) treatment within 28 days,
- Radioimmunoconjugates or toxin conjugates within 12 weeks.
- Prior Chimeric antigen receptor (CAR) T cell therapy (and prior use of
immunoglobulin replacement therapy to treat associated adverse events) within 3
months. For patients with DLBCL, no prior CAR- T therapy is allowed.
- Autologous or allogenic stem cell transplant within 100 days and must not have
ongoing graft-versus-host disease (GVHD) and no ongoing therapy to treat GVHD.
2. History of central nervous system lymphoma/leukemia in remission for less than 2
years.
3. Medical history of active bleeding within 2 months prior to study entry, or
susceptible to bleeding by the judgement of investigator.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05780034.
Locations matching your search criteria
United States
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Temporarily closed to accrual
Name Not Available
Oregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not Available
Texas
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
Status: Active
Name Not Available
AC676-001 is a Phase I, first-in-human, open-label, multi-center dose-escalation study of
AC676 given as a single agent. AC676 is an investigational medicinal product that is an
orally bioavailable BTK degrader for the treatment of B-cell malignancies.