Actively Recruiting
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
Led by Accutar Biotechnology Inc · Updated on 2025-10-02
60
Participants Needed
9
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AC676, an investigational oral drug that targets BTK, in adult participants with relapsed or refractory B-cell malignancies such as Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Marginal Zone Lymphoma, or Waldenström Macroglobulinemia. This Phase I, first-in-human, open-label study aims to find a safe and recommended dose, assess safety, study how the drug is processed in the body, and evaluate early signs of effectiveness. Participants will receive assigned doses of AC676 taken orally in repeated 28-day cycles. The study includes a dose-escalation phase to determine the maximum tolerated dose or recommended Phase II dose. Treatment details and dosing frequency are standardized in each cycle to monitor drug effects and safety. During the trial, researchers will closely observe participants for any dose-limiting toxicities, treatment-related side effects, and lab abnormalities over approximately 18 months. They will collect blood samples to analyze drug levels and monitor response using measures such as objective response rate, duration and time to response, disease control rate, and progression-free survival. The total study duration includes ongoing safety and effectiveness assessments, ensuring comprehensive evaluation of AC676 in this patient group.
CONDITIONS
Brief Title
A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male and female patients aged 18 years or older at the time of signing informed consent
- Histologically confirmed diagnosis of relapsed or refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, non-GCB Diffuse Large B-cell Lymphoma, Marginal Zone Lymphoma, or Waldenström Macroglobulinemia
- Must have received at least two prior systemic therapies or have no other therapies expected to provide significant clinical benefit, or be intolerant or unwilling to standard therapies
You will not qualify if you...
- Treatment with 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 CAR T-cell therapy within 3 months; no prior CAR T therapy allowed for Diffuse Large B-cell Lymphoma patients
- Autologous or allogenic stem cell transplant within 100 days; no ongoing graft-versus-host disease or treatment for it
- History of central nervous system lymphoma or leukemia in remission for less than 2 years
- Active bleeding within 2 months before study entry or judged susceptible to bleeding by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive oral AC676 treatment in repeated 28-day cycles as part of dose escalation to evaluate safety and dosing.
Visits occur regularly during each 28-day cycle
Duration - Up to approximately 18 months
Participants are monitored for safety, treatment response, and long-term outcomes after treatment ends.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 9 locations
1
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Actively Recruiting
2
Florida Cancer Specialists
Sarasota, Florida, United States, 34232
Actively Recruiting
3
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
4
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
5
The Ohio State University - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States, 43210
Actively Recruiting
6
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
7
Tennessee Oncology
Nashville, Tennessee, United States, 37302
Withdrawn
8
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
9
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Actively Recruiting
Research Team
A
Accutar Biotechnology
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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