Recruiting
Phase 1

AC676

Sponsor:

Accutar Biotechnology Inc

Code:

NCT05780034

Conditions

Relapsed/Refractory B-cell Malignancies

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AC676

Study Details

Brief 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

Conditions

Relapsed/Refractory B-cell Malignancies

Study ID

NCT05780034

Start date

Jun 20, 2023

Status verified date

Sep, 2025

Completion date

May 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

60 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AC676 Dose Escalation

Participants will receive an assigned dose of AC676 in a 28-days cycle.

Interventions

AC676

AC676 will be given orally (PO) on a 28-day cycle.

Primary outcome measure

  • Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy [ Time Frame: 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. [ Time Frame: Approximately 18 months ]
  • Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) [ Time Frame: Approximately 18 months ]

Central Contacts and Locations

Central contacts

Locations

Colorado Blood Cancer Institute

Recruiting

Denver, Colorado, United States, 80218

Florida Cancer Specialists

Recruiting

Sarasota, Florida, United States, 34232

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

The Ohio State University - The James Cancer Hospital and Solove Research Institute

Recruiting

Columbus, Ohio, United States, 43210

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Swedish Cancer Institute

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Accutar Biotechnology Inc

Last update posted

Oct 2, 2025

Last verified

Sep, 2025

Keywords

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
  • Mantle Cell Lymphoma (MCL)
  • Follicular Lymphoma (FL)
  • Non-Germinal Center B-cell (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
  • Marginal Zone Lymphoma (MZL
  • Waldenström Macroglobulinemia (WM)
  • Non-Hodgkin Lymphoma (NHL)
  • Bruton's tyrosine kinase-BTK
  • BTK Degrader
  • AC676
  • AC0676

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Accutar Biotechnology Inc on 2025-10-02.