Relapsed/Refractory B-cell MalignanciesPhase 1NCT05780034
A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies
A Phase 1 study testing AC676 in people with Relapsed/Refractory B-cell Malignancies, run by Accutar Biotechnology Inc at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory B-cell Malignancies
- What is being tested?
- AC676
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesUnited States
- Study dates
- 20 Jun 2023to 31 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
The Ohio State University - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Withdrawn
Tennessee Oncology
Nashville, Tennessee, 37302
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
- Recruiting
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
Official title: 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
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
Read the 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.
- Conditions
- Relapsed/Refractory B-cell Malignancies
- Being tested
- AC676
- 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
- Medical subject headings
- Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC676Drug
AC676 will be given orally (PO) on a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| AC676 Dose Escalation | Experimental | Participants will receive an assigned dose of AC676 in a 28-days cycle. Receives: Drug: AC676 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy
Measured: 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.
Measured: Approximately 18 months
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)
Measured: Approximately 18 months
Secondary outcomes (10)
Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf))
Measured: Up to approximately 20 weeks
Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau))
Measured: Up to approximately 20 weeks
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Measured: Up to approximately 20 weeks
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Measured: Up to approximately 20 weeks
Pharmacokinetic Analysis: terminal elimination half-life (t1/2)
Measured: Up to approximately 20 weeks
Objective Response Rate (ORR) in patients receiving AC676
Measured: Approximately 18 months
Duration of Response (DOR) in patients receiving AC676
Measured: Approximately 18 months
Time to Response (TTR) in patients receiving AC676
Measured: Approximately 18 months
Disease Control Rate (DCR) in patients receiving AC676
Measured: Approximately 18 months
Progression Free Survival rate (PFS) in patients receiving AC676
Measured: Approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start20 Jun 2023
- Primary completion31 Mar 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory B-cell MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Accutar Biotechnology Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780034
- Sponsor's protocol ID
- AC676-001
- Status last verified
- Sep 2025
- First submitted
- 10 Mar 2023
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05780034
- Acronym / sponsor ID
- AC676-001
- Conditions
- Relapsed/Refractory B-cell Malignancies
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Accutar Biotechnology IncIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AC676 Dose Escalation | Experimental | Drug: AC676Participants will receive an assigned dose of AC676 in a 28-days cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Treatment with any of the following:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC676AC676 will be given orally (PO) on a 28-day cycle. | Drug | AC676 Dose Escalation |
Primary outcome
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy
Time frame: 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.
Time frame: Approximately 18 months
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)
Time frame: Approximately 18 months
10 secondary outcomes
Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf))
Time frame: Up to approximately 20 weeks
Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau))
Time frame: Up to approximately 20 weeks
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Time frame: Up to approximately 20 weeks
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Time frame: Up to approximately 20 weeks
Pharmacokinetic Analysis: terminal elimination half-life (t1/2)
Time frame: Up to approximately 20 weeks
Objective Response Rate (ORR) in patients receiving AC676
Time frame: Approximately 18 months
Duration of Response (DOR) in patients receiving AC676
Time frame: Approximately 18 months
Time to Response (TTR) in patients receiving AC676
Time frame: Approximately 18 months
Disease Control Rate (DCR) in patients receiving AC676
Time frame: Approximately 18 months
Progression Free Survival rate (PFS) in patients receiving AC676
Time frame: Approximately 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AC676 in people with Relapsed/Refractory B-cell Malignancies, run by Accutar Biotechnology Inc at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Accutar Biotechnology (908-340-0879, medical@accutarbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy (time frame: From cycle 1 day 1 to Cycle 1 day 28. Cycles are 28 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.