A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies
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
1 other identifier
interventional
60
1 country
9
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2023
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2023
CompletedFirst Posted
Study publicly available on registry
March 22, 2023
CompletedStudy Start
First participant enrolled
June 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedOctober 2, 2025
September 1, 2025
2.8 years
March 10, 2023
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy
From cycle 1 day 1 to Cycle 1 day 28. Cycles are 28 days.
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher laboratory abnormalities using CTCAE v5.0 criteria.
Approximately 18 months
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)
Approximately 18 months
Secondary Outcomes (10)
Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf))
Up to approximately 20 weeks
Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau))
Up to approximately 20 weeks
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Up to approximately 20 weeks
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Up to approximately 20 weeks
Pharmacokinetic Analysis: terminal elimination half-life (t1/2)
Up to approximately 20 weeks
- +5 more secondary outcomes
Study Arms (1)
AC676 Dose Escalation
EXPERIMENTALParticipants will receive an assigned dose of AC676 in a 28-days cycle.
Interventions
Eligibility Criteria
You may qualify if:
- Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF).
- 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).
- 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.
You may not qualify if:
- Patients who meet any of the following criteria will be excluded from study entry:
- 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.
- History of central nervous system lymphoma/leukemia in remission for less than 2 years.
- Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2023
First Posted
March 22, 2023
Study Start
June 20, 2023
Primary Completion
March 31, 2026
Study Completion (Estimated)
May 31, 2026
Last Updated
October 2, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share