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

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

NCT ID: NCT05780034

Condition: Relapsed/Refractory B-cell Malignancies

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
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

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: AC676
Description: AC676 will be given orally (PO) on a 28-day cycle.
Arm group label: AC676 Dose Escalation

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Colorado Blood Cancer Institute

Address:
City: Denver
Zip: 80218
Country: United States

Status: Recruiting

Facility:
Name: Florida Cancer Specialists

Address:
City: Sarasota
Zip: 34232
Country: United States

Status: Recruiting

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

Address:
City: Columbus
Zip: 43210
Country: United States

Status: Recruiting

Facility:
Name: Oregon Health & Science University

Address:
City: Portland
Zip: 97239
Country: United States

Status: Recruiting

Facility:
Name: Tennessee Oncology

Address:
City: Nashville
Zip: 37302
Country: United States

Status: Withdrawn

Facility:
Name: University of Texas Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Status: Recruiting

Facility:
Name: Swedish Cancer Institute

Address:
City: Seattle
Zip: 98104
Country: United States

Status: Recruiting

Start date: June 20, 2023

Completion date: December 2025

Lead sponsor:
Agency: Accutar Biotechnology Inc
Agency class: Industry

Source: Accutar Biotechnology Inc

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05780034