RECRUITING

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

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Conditions

Relapsed/Refractory B-cell MalignanciesChronic Lymphocytic Leukemia (CLL)Small Lymphocytic Lymphoma (SLL)Mantle Cell Lymphoma (MCL)Follicular Lymphoma (FL)Non-Germinal Center B-cell (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)Marginal Zone Lymphoma (MZLWaldenström Macroglobulinemia (WM)Non-Hodgkin Lymphoma (NHL)Bruton's tyrosine kinase-BTKBTK DegraderAC676AC0676

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

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

Quick Facts

Study Start:2023-06-20
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05780034

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).
  2. 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. 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. 1. Treatment with any of the following:
  2. * Small molecule anti-cancer drugs within 5 half-lives or 2 days (whichever is longer, not to exceed 14 days).
  3. * Systemic chemotherapy within 14 days.
  4. * Radiation therapy within 14 days
  5. * Biologics (Antibodies) treatment within 28 days,
  6. * Radioimmunoconjugates or toxin conjugates within 12 weeks.
  7. * 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.
  8. * 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.
  9. 2. History of central nervous system lymphoma/leukemia in remission for less than 2 years.
  10. 3. Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.

Contacts and Locations

Study Contact

Accutar Biotechnology
CONTACT
908-340-0879
medical@accutarbio.com

Study Locations (Sites)

Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
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

Collaborators and Investigators

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 Registration Dates

Study Start Date2023-06-20
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-06-20
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
  • Mantle Cell Lymphoma (MCL)
  • Follicular Lymphoma (FL)
  • Non-Germinal Center B-cell (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL)
  • Marginal Zone Lymphoma (MZL
  • Waldenström Macroglobulinemia (WM)
  • Non-Hodgkin Lymphoma (NHL)
  • Bruton's tyrosine kinase-BTK
  • BTK Degrader
  • AC676
  • AC0676

Additional Relevant MeSH Terms

  • Relapsed/Refractory B-cell Malignancies