Treatment of relapsed/refractory B-cell cancers with AC676

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the investigational drug AC676 in patients with relapsed or refractory B-cell malignancies. It is a Phase I, open-label, multi-center dose-escalation study aimed at determining the recommended safe dose of AC676, assessing its safety profile, and evaluating its pharmacokinetics and effectiveness. Participants will receive AC676 as a single agent to understand its potential benefits in treating various B-cell cancers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Colorado Blood Cancer Institute
  Denver, Colorado, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• The Ohio State University - The James Cancer Hospital and Solove Research Institute
  Columbus, Ohio, United States Recruiting
• Oregon Health & Science University
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Accutar Biotechnology
• Email: medical@accutarbio.com
• Phone: 908-340-0879

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.