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NCT05780034PHASE1Recruiting

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

Accutar Biotechnology Inc

Start Date

6/20/2023

Completion Date

5/31/2026

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

AC676

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Conditions

Relapsed/Refractory B-cell Malignancies

Locations

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Florida Cancer Specialists

Sarasota, Florida 34232

United States

University of North Carolina

Chapel Hill, North Carolina 27599

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

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

Columbus, Ohio 43210

United States

Oregon Health & Science University

Portland, Oregon 97239

United States

Tennessee Oncology

Nashville, Tennessee 37302

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Swedish Cancer Institute

Seattle, Washington 98104

United States