RecruitingRecruiting
A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies
NCT05780034 · Accutar Biotechnology Inc
In plain English
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Official title
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
About this study
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.
Eligibility 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 design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-06-20
Estimated completion: 2026-05-31
Last updated: 2025-10-02
Interventions
Drug: AC676
Primary outcomes
- • 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)
Sponsor
Accutar Biotechnology Inc · industry
Contacts & investigators
ContactAccutar Biotechnology · contact · medical@accutarbio.com · 908-340-0879
All locations (9)
Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, United States
Florida Cancer SpecialistsRecruiting
Sarasota, Florida, United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
The Ohio State University - The James Cancer Hospital and Solove Research InstituteRecruiting
Columbus, Ohio, United States
Oregon Health & Science UniversityRecruiting
Portland, Oregon, United States
Tennessee OncologyWithdrawn
Nashville, Tennessee, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Swedish Cancer InstituteRecruiting
Seattle, Washington, United States