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

Last updated: September 29, 2025
Sponsor: Accutar Biotechnology Inc
Overall Status: Active - Recruiting

Phase

1

Condition

Waldenstrom Macroglobulinemia

Lymphoma, B-cell

Lymphocytic Leukemia, Chronic

Treatment

AC676

Clinical Study ID

NCT05780034
AC676-001
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Adult male and female patients, at least 18 years-of-age at the time of signature ofthe informed consent form (ICF).

  2. Patients with histologically confirmed relapsed/refractory Chronic LymphocyticLeukemia (CLL), Small Lymphocytic Lymphoma (SLL), Mantle Cell Lymphoma (MCL),Follicular Lymphoma (FL), non-GCB Diffuse Large B-cell Lymphoma (DLBCL), MarginalZone Lymphoma (MZL), or Waldenström Macroglobulinemia (WM).

  3. Must have received at least 2 prior systemic therapies or have no other therapies toprovide significant clinical benefit in the opinion of the Investigator or who arenot amenable (intolerability, patient choice) to standard therapies.

Exclusion

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 islonger, 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 ofimmunoglobulin replacement therapy to treat associated adverse events) within 3months. For patients with DLBCL, no prior CAR- T therapy is allowed.

  • Autologous or allogenic stem cell transplant within 100 days and must not haveongoing graft-versus-host disease (GVHD) and no ongoing therapy to treat GVHD.

  1. History of central nervous system lymphoma/leukemia in remission for less than 2years.

  2. Medical history of active bleeding within 2 months prior to study entry, orsusceptible to bleeding by the judgement of investigator.

Study Design

Total Participants: 60
Treatment Group(s): 1
Primary Treatment: AC676
Phase: 1
Study Start date:
June 20, 2023
Estimated Completion Date:
May 31, 2026

Study 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.

Connect with a study center

  • Colorado Blood Cancer Institute

    Denver, Colorado 80218
    United States

    Site Not Available

  • Site 03

    Denver, Colorado 80218
    United States

    Active - Recruiting

  • Colorado Blood Cancer Institute

    Denver 5419384, Colorado 5417618 80218
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida 34232
    United States

    Site Not Available

  • Site 02

    Sarasota, Florida 34232
    United States

    Active - Recruiting

  • Florida Cancer Specialists

    Sarasota 4172131, Florida 4155751 34232
    United States

    Active - Recruiting

  • University of North Carolina

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

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

    Columbus, Ohio 43210
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland 5150529, Ohio 5165418 44106
    United States

    Active - Recruiting

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

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • Oregon Health & Science University

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Site 01

    Nashville, Tennessee 37302
    United States

    Active - Recruiting

  • Tennessee Oncology

    Nashville, Tennessee 37302
    United States

    Site Not Available

  • Tennessee Oncology

    Nashville 4644585, Tennessee 4662168 37302
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center

    Dallas 4684888, Texas 4736286 75390
    United States

    Active - Recruiting

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle 5809844, Washington 5815135 98104
    United States

    Active - Recruiting

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