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

Description

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 Overview

Study Details

Study overview

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

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

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

Condition
Relapsed/Refractory B-cell Malignancies
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Columbus

The Ohio State University - The James Cancer Hospital and Solove Research Institute, Columbus, Ohio, United States, 43210

Portland

Oregon Health & Science University, Portland, Oregon, United States, 97239

Nashville

Tennessee Oncology, Nashville, Tennessee, United States, 37302

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75390

Seattle

Swedish Cancer Institute, Seattle, Washington, United States, 98104

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Accutar Biotechnology Inc,

Study Record Dates

2025-12