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A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT05780034•Accutar Biotechnology Inc

View on ClinicalTrials.gov

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (9)

Colorado Blood Cancer Institute

Denver, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

University of North Carolina

Chapel Hill, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

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

Columbus, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Tennessee Oncology

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Swedish Cancer Institute

Seattle, Washington, United States

Key Dates

Start Date

June 20, 2023

Primary Completion Date

March 31, 2026

Completion Date

May 31, 2026

Last Updated

October 2, 2025

Enrollment

ESTIMATED participants

Conditions

Relapsed/Refractory B-cell Malignancies

Interventions

AC676

DRUG

Contacts

Accutar Biotechnology

CONTACT

908-340-0879 medical@accutarbio.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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