Testing AC676 in adults with returned B-cell blood cancers
Tests a new drug, AC676, in adults whose B-cell blood cancer returned or stopped responding.
Plain-language title generated from the registry record
Registry title: A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies
Key facts
- Where
- Chapel Hill, Cleveland, Columbus, Dallas, Denver, Nashville, Portland, Sarasota, and Seattle, United StatesSee the 9 sites
- Phase
- Phase 1
Where in United States
- University of North CarolinaChapel Hill, United StatesTaking people
- University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
- The Ohio State University - The James Cancer Hospital and Solove Research InstituteColumbus, United StatesTaking people
- University of Texas Southwestern Medical CenterDallas, United StatesTaking people
- Colorado Blood Cancer InstituteDenver, United StatesTaking people
- Tennessee OncologyNashville, United StatesNo longer taking part
- Oregon Health Science UniversityPortland, United StatesTaking people
- Florida Cancer SpecialistsSarasota, United StatesTaking people
- Swedish Cancer InstituteSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Accutar Biotechnology Inc
- Trial code
- NCT05780034
- Record updated
- 2 October 2025
- Original description
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:Read full original descriptionShow less
A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Malignancy Activity of AC676 in Patients With Relapsed/Refractory B-cell Malignancies
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: 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.
Exclusion: 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; Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator; History of central nervous system lymphoma/leukemia in remission for less than 2 years; Patients who meet any of the following criteria will be excluded from study entry:.