ClinicalTrials.gov record NCT05780034
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
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a first-in-human Phase I, open-label dose-escalation study of oral AC676 given alone in 28-day cycles. It enrolls adults with relapsed or refractory B‑cell malignancies to identify a recommended Phase II dose and assess safety, drug levels in the body, and early signs of anti-cancer activity. The study monitors side effects and laboratory safety over about 18 months, with earlier pharmacokinetic sampling.
What it is studying. The study is testing AC676, an investigational orally taken BTK degrader, given as a single agent. It aims to find the dose that can be given safely (maximum tolerated dose and/or recommended Phase II dose), to describe side effects and pharmacokinetics, and to look for early anti‑malignancy effects in people with relapsed/refractory B‑cell cancers.
What the researchers hope to learn. Scientific goals: identify the recommended Phase II dose and maximum tolerated dose of AC676; describe its safety and treatment‑emergent adverse events; measure pharmacokinetic parameters (AUC, Cmax, tmax, t1/2); and collect preliminary measures of anti‑malignancy activity (objective response rate, duration of response, time to response, disease control rate, and progression‑free survival).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- AC676
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants are assigned a dose of AC676 and take the drug by mouth in 28‑day treatment cycles as part of a dose‑escalation plan. They will make regular clinic visits for safety checks and monitoring, including laboratory tests and pharmacokinetic blood testing to measure drug levels, and scheduled assessments to check disease response. The study focuses on tracking dose‑limiting toxicities, adverse events, and laboratory changes; some safety and response assessments continue for many weeks to months (PK testing up to about 20 weeks and other outcomes observed up to about 18 months).
How the study is structured. Participants receive assigned doses of oral AC676 in 28‑day treatment cycles in a sequential dose‑escalation plan (no placebo, open‑label). The first cycle is closely evaluated for dose‑limiting toxicities (cycle 1 day 1 to day 28); safety monitoring, blood sampling for pharmacokinetics, and tumor/clinical assessments continue over the planned study period (safety outcomes ~18 months; some PK measures up to ~20 weeks).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- Jun 20, 2023
- Primary completion
- Mar 31, 2026 (estimated)
- Study completion
- May 31, 2026 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- Oct 2, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Accutar Biotechnology Inc
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Accutar Biotechnology 📞 908-340-0879 ✉ medical@accutarbio.com
Participating sites (9)
- Colorado Blood Cancer InstituteRecruiting
Denver, Colorado, 80218 · United States
- Florida Cancer SpecialistsRecruiting
Sarasota, Florida, 34232 · United States
- University of North CarolinaRecruiting
Chapel Hill, North Carolina, 27599 · United States
- University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, 44106 · United States
- The Ohio State University - The James Cancer Hospital and Solove Research InstituteRecruiting
Columbus, Ohio, 43210 · United States
- Oregon Health & Science UniversityRecruiting
Portland, Oregon, 97239 · United States
- Tennessee OncologyWithdrawn
Nashville, Tennessee, 37302 · United States
- University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, 75390 · United States
- Swedish Cancer InstituteRecruiting
Seattle, Washington, 98104 · United States
Terms used on this page · explanations by MedicalUpdates.ai
- Relapsed/Refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- pharmacokinetics
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- histologically confirmed
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- Chimeric antigen receptor
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- adverse events
- Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
- stem cell transplant
- A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- first-in-human
- The first study in which a treatment is given to people. Safety is the main question and the number of participants is usually small.
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- dose-escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials