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

{ "A Study of AC676 for Relapsed/Refractory B-Cell Malignancies", "This study is testing a new oral drug called AC676 for people with B-cell malignancies (cancers of certain white blood cells) that have returned or not responded to previous treatments. The main goals are to find a safe dose of AC676, understand its side effects, and see how well it works. AC676 works by targeting a specific protein called BTK, which is involved in the growth of these cancer cells. You may be able to join if you are at least 18 years old and have a confirmed diagnosis of certain types of relapsed/refractory B-cell lymphomas or leukemia. The study aims to enroll about 60 participants.", "design": "This is a Phase 1, first-in-human study where all participants will receive AC676. It is an open-label study, meaning both you and your doctors will know you are receiving the study drug.", "commitments": "AC676 will be taken by mouth in 28-day cycles. The study will monitor for side effects and laboratory changes for approximately 18 months.", "compensation": "Not stated in the trial record.", "follow_up": "The study will track side effects and laboratory changes for approximately 18 months after treatment begins.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05780034

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Accutar Biotechnology Inc
~60 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:AC676

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy
Measured over From cycle 1 day 1 to Cycle 1 day 28. Cycles are 28 days.
+2 more outcomes measured
Relapsed/Refractory B-cell Malignancies
9 sites across 8 states
Ohio2
Colorado1
Florida1
North Carolina1
Oregon1
Tennessee1
Texas1
Washington1

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Eligibility criteria

Exclusion

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.
  • Incidence of dose limiting toxicities (DLTs) from AC676 monotherapyFrom 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