BridgeMD
New treatment option for Relapsed/Refractory B-cell Malignancies
Official title A Study of AC676 for the Treatment of Relapsed/Refractory B-Cell Malignancies
ClinicalTrials.gov ID: NCT05780034
What this study is testing
What is AC676?
AC676 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for relapsed/refractory b-cell malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Must have received at least 2 prior systemic therapies or have no other therapies to provide significant clinical benefit in the opinion of the...
You likely can't join if
- 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,
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Sarasota, Florida, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Sarasota, Florida, United States; Chapel Hill, North Carolina, United States; Cleveland, Ohio, United States; Columbus, Ohio, United States; Portland, Oregon, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.