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 range18 Years

SexALL

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.
✕. Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.

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 range18 Years

SexALL

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.
✕. Medical history of active bleeding within 2 months prior to study entry, or susceptible to bleeding by the judgement of investigator.

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