A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies

Recruiting now · Phase 1

Conditions studied: Relapsed/Refractory B-cell Malignancies

In brief

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

Key facts

Study ID

NCT05780034

Run by

Accutar Biotechnology Inc

People needed

60

Starts

2023-06-20

Expected to finish

2026-05-31

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).
• 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).
• 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.

You may not qualify if…

• Patients who meet any of the following criteria will be excluded from study entry:
• 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.
• History of central nervous system lymphoma/leukemia in remission for less than 2 years.
• Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.

Where it is running

• Swedish Cancer Institute — Seattle, Washington, United States (enrolling)
• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• University of North Carolina — Chapel Hill, North Carolina, United States (enrolling)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (enrolling)
• The Ohio State University - The James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Colorado Blood Cancer Institute — Denver, Colorado, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Tennessee Oncology — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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