AC676: AC676 will be given orally (PO) on a 28-day cycle.
Study summary
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy — From cycle 1 day 1 to Cycle 1 day 28. Cycles are 28 days.
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher laboratory abnormalities using CTCAE v5.0 criteria. — Approximately 18 months
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) — Approximately 18 months
Trial sites (9)
Facility
City
Region
Status
Colorado Blood Cancer Institute
Denver
Colorado
Recruiting
Florida Cancer Specialists
Sarasota
Florida
Recruiting
University of North Carolina
Chapel Hill
North Carolina
Recruiting
University Hospitals Cleveland Medical Center
Cleveland
Ohio
Recruiting
The Ohio State University - The James Cancer Hospital and Solove Research Institute
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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