Non Hodgkin Lymphoma Clinical Trial

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

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

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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:

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,
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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05780034

Recruitment Status:

Recruiting

Sponsor:

Accutar Biotechnology Inc

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There are 6 Locations for this study

See Locations Near You

Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Florida Cancer Specialists
Sarasota Florida, 34232, United States
The Ohio State University - The James Cancer Hospital and Solove Research Institute
Columbus Ohio, 43210, United States
Tennessee Oncology
Nashville Tennessee, 37302, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT05780034

Recruitment Status:

Recruiting

Sponsor:


Accutar Biotechnology Inc

How clear is this clinincal trial information?

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