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Clinical Trials in the USA / NCT05780034
Recruiting Phase 1

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

NCT05780034 · tracked via the Priya Life Science USA tracker
Sponsor
Accutar Biotechnology Inc
Phase
Phase 1
Started
2023-06-20
Last updated
2025-10-02

Condition(s) studied

Relapsed/Refractory B-cell Malignancies

Investigational drug(s) / intervention(s)

AC676

AC676: AC676 will be given orally (PO) on a 28-day cycle.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Adult male and female patients, at least 18 years-of-age at the time of signature of the informed consent form (ICF). 2. 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). 3. 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: 1. 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. 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.

Primary outcome measure(s)

Trial sites (9)

FacilityCityRegionStatus
Colorado Blood Cancer Institute Denver Colorado Recruiting
Florida Cancer Specialists Sarasota Florida Recruiting
University of North Carolina Chapel Hill North Carolina Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
The Ohio State University - The James Cancer Hospital and Solove Research Institute Columbus Ohio Recruiting
Oregon Health & Science University Portland Oregon Recruiting
Tennessee Oncology Nashville Tennessee Withdrawn
University of Texas Southwestern Medical Center Dallas Texas Recruiting
Swedish Cancer Institute Seattle Washington Recruiting

More Accutar Biotechnology Inc trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05780034 on ClinicalTrials.gov ↗ ← All trials in the USA