RecruitingPhase 1

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

United States60 participantsStarted 2023-06-20

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

. Treatment with any of the following:
. History of central nervous system lymphoma/leukemia in remission for less than 2 years.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy

Timeframe: 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.

Timeframe: Approximately 18 months

Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)

Timeframe: Approximately 18 months

Trial details

NCT IDNCT05780034

SponsorAccutar Biotechnology Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-31

Contact for this trial

Accutar Biotechnology

908-340-0879 medical@accutarbio.com

View on ClinicalTrials.gov More Relapsed/Refractory B-cell Malignancies trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

. Treatment with any of the following:
. History of central nervous system lymphoma/leukemia in remission for less than 2 years.

What they're measuring

Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy

Timeframe: 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.

Timeframe: Approximately 18 months

Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)

Timeframe: Approximately 18 months