Treatment of relapsed/refractory B-cell cancers with AC676
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
PHASE1 · Accutar Biotechnology Inc · NCT05780034
This study is testing a new drug called AC676 to see if it can help people with tough-to-treat B-cell cancers feel better.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Accutar Biotechnology Inc (industry) |
| Drugs / interventions | Chimeric antigen receptor, chemotherapy, Radiation |
| Locations | 9 sites (Denver, Colorado and 8 other locations) |
| Trial ID | NCT05780034 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the investigational drug AC676 in patients with relapsed or refractory B-cell malignancies. It is a Phase I, open-label, multi-center dose-escalation study aimed at determining the recommended safe dose of AC676, assessing its safety profile, and evaluating its pharmacokinetics and effectiveness. Participants will receive AC676 as a single agent to understand its potential benefits in treating various B-cell cancers.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed relapsed or refractory B-cell malignancies who have received at least two prior systemic therapies.
Not a fit: Patients who have recently undergone treatment with certain anti-cancer drugs or systemic chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.
How similar studies have performed: Other studies involving BTK inhibitors have shown promise in treating B-cell malignancies, suggesting a potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Denver, Colorado and 8 other locations
- Colorado Blood Cancer Institute — Denver, Colorado, United States (RECRUITING)
- Florida Cancer Specialists — Sarasota, Florida, United States (RECRUITING)
- University of North Carolina — Chapel Hill, North Carolina, United States (RECRUITING)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
- The Ohio State University - The James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States (RECRUITING)
- Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)
- Tennessee Oncology — Nashville, Tennessee, United States (WITHDRAWN)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
- Swedish Cancer Institute — Seattle, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Accutar Biotechnology
- Email: medical@accutarbio.com
- Phone: 908-340-0879
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Relapsed/Refractory B-cell Malignancies, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Non-Germinal Center B-cell Diffuse Large B-cell Lymphoma, Marginal Zone Lymphoma (MZL, Waldenström Macroglobulinemia