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

September 29, 2025 updated by: Accutar Biotechnology Inc

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialists
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University - The James Cancer Hospital and Solove Research Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
    • Tennessee
      • Nashville, Tennessee, United States, 37302
        • Withdrawn
        • Tennessee Oncology
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AC676 Dose Escalation
Participants will receive an assigned dose of AC676 in a 28-days cycle.
Drug: AC676
AC676 will be given orally (PO) on a 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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
Approximately 18 months
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)
Time Frame: Approximately 18 months
Approximately 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf))
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau))
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
Pharmacokinetic Analysis: terminal elimination half-life (t1/2)
Time Frame: Up to approximately 20 weeks
Up to approximately 20 weeks
Objective Response Rate (ORR) in patients receiving AC676
Time Frame: Approximately 18 months
Approximately 18 months
Duration of Response (DOR) in patients receiving AC676
Time Frame: Approximately 18 months
Approximately 18 months
Time to Response (TTR) in patients receiving AC676
Time Frame: Approximately 18 months
Approximately 18 months
Disease Control Rate (DCR) in patients receiving AC676
Time Frame: Approximately 18 months
Approximately 18 months
Progression Free Survival rate (PFS) in patients receiving AC676
Time Frame: Approximately 18 months
Approximately 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accutar Biotechnology Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

September 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC676-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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