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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 18 months
Awards & highlights
Study Summary
This trial tests a drug to safely and effectively treat cancer that has come back or does not respond to treatment.
Who is the study for?
This trial is for adults with certain types of B-cell malignancies that have come back or didn't respond to treatment. They must have tried at least two treatments already, or be unable to use standard therapies. People can't join if they've had recent cancer treatments, stem cell transplants, CAR-T therapy (for DLBCL patients), active bleeding issues, or are within a specific timeframe after receiving other specific therapies.Check my eligibility
What is being tested?
The study tests AC676 in participants with relapsed/refractory B-cell malignancies. It aims to find the safest dose, understand side effects and how the body processes the drug (pharmacokinetics), and assess its effectiveness against these blood cancers.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions related to immune system activation such as fever and fatigue; organ-specific inflammation; infusion-related reactions; blood count changes leading to increased infection risk; and possible impact on liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher laboratory abnormalities using CTCAE v5.0 criteria.
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)
Secondary outcome measures
Disease Control Rate (DCR) in patients receiving AC676
Duration of Response (DOR) in patients receiving AC676
Objective Response Rate (ORR) in patients receiving AC676
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: AC676 Dose EscalationExperimental Treatment1 Intervention
Participants will receive an assigned dose of AC676 in a 28-days cycle.
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Who is running the clinical trial?
Accutar Biotechnology IncLead Sponsor
5 Previous Clinical Trials
123 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is one of the specified types and has come back or didn't respond to treatment.I am an adult, 18 years or older, and can sign the consent form.My CNS lymphoma/leukemia has been in remission for less than 2 years.I haven't taken any cancer drugs within the last 2 weeks.I haven't had chemotherapy in the last 14 days.I haven't had treatments with radioimmunoconjugates or toxin conjugates in the last 12 weeks.I have undergone radiation therapy in the last 14 days.I had a stem cell transplant within the last 100 days and am being treated for GVHD.I have undergone at least 2 treatments or cannot take standard treatments according to my doctor.I have not had CAR T cell therapy in the last 3 months.I haven't taken any biologic (antibody) treatments in the last 28 days.
Research Study Groups:
This trial has the following groups:- Group 1: AC676 Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the AC676 Dose Escalation achieved regulatory sanction from the FDA?
"The safety and efficacy of AC676 Dose Escalation has not been extensively researched, thus it was rated a 1 on our scale. This is due to its Phase 1 status."
Answered by AI
What is the aggregate count of individuals involved in this clinical evaluation?
"Yes, according to clinicaltrials.gov this study is still open for recruitment since it was last updated on August 11th 2023. The trial was initially uploaded on June 20th of the same year and requires 60 individuals from 3 sites."
Answered by AI
Are there any openings available for enrolment in this trial?
"As indicated on clinicaltrials.gov, this medical trial is still open for recruitment of participants. It was first listed on June 20th 2023 and the information has been recently updated as of August 11th 23rd."
Answered by AI
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