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AS-1763 for Chronic Lymphocytic Leukemia
Phase 1
Recruiting
Research Sponsored by Carna Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years
Histologically confirmed B-cell malignancy, including CLL/SLL, WM, MCL, MZL, or FL. Patients must have failed or are intolerant to ≥2 prior lines of systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights
Study Summary
This trial tests a new drug to treat a type of blood cancer in patients who have already tried other treatments.
Who is the study for?
This trial is for adults over 18 with certain B-cell cancers like CLL/SLL or NHL who have tried at least two other treatments without success. They must be able to swallow pills, perform daily activities with minimal help, and use effective birth control. People can't join if they have cancer in the brain, uncontrolled infections or autoimmune diseases, recent heart issues, are pregnant or breastfeeding, HIV positive, or have had recent major surgery.Check my eligibility
What is being tested?
The study tests AS-1763—an oral medication—on patients with specific types of blood cancers that haven't responded well to previous therapies. It's an early-phase trial (Phase 1b) where everyone gets the same treatment to see how safe it is and what effects it has.See study design
What are the potential side effects?
Potential side effects aren't detailed here but could include typical reactions seen with cancer medications such as nausea, fatigue, allergic reactions to ingredients in AS-1763, liver problems due to hepatic function requirements for eligibility criteria.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My cancer is a type of B-cell malignancy and I've tried at least 2 treatments that didn't work or couldn't tolerate.
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I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD)
Overall response rate (ORR) as assessed by investigator
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC) of AS-1763
Best overall response as assessed by investigator
Duration of response as assessed by investigator
+6 moreOther outcome measures
Proportion of patients with BTK and PLCG2 gene mutation before and after disease progression
Trial Design
3Treatment groups
Experimental Treatment
Group I: Dose Expansion Cohort 2Experimental Treatment1 Intervention
B-cell NHL patients previously treated with ≥2 lines of systemic therapy will self-administer AS-1763 oral tablet for 24 cycles (1 cycle = 28 days). Dose levels will be determined based on the result of dose escalation part.
Group II: Dose Expansion Cohort 1Experimental Treatment1 Intervention
CLL/SLL patients previously treated with ≥2 lines of systemic therapy will self-administer AS-1763 oral tablet for 24 cycles (1 cycle = 28 days). Dose levels will be determined based on the result of dose escalation part.
Group III: Dose EscalationExperimental Treatment1 Intervention
Dose escalation (3+3 design) and determination of MTD and DLTs
CLL/SLL or B-cell NHL patients previously treated with ≥2 lines of systemic therapy will self-administer AS-1763 oral tablet at multiple dose levels twice daily for 24 cycles (1 cycle = 28 days).
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Who is running the clinical trial?
Carna Biosciences, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have serious heart issues or a recent heart attack.I do not have any ongoing serious infections.My kidneys are working well.I have an autoimmune blood disorder that hasn't been stable for the last 4 weeks.I have another cancer type but it's in remission and I'm expected to live more than 2 years.I haven't taken any cancer drugs or investigational treatments recently.My lymphoma has spread to my brain or spinal cord, but I am stable after treatment.I am willing to use effective birth control methods.I am on warfarin for blood clot treatment.I don't have lasting side effects from previous treatments, except for hair loss.My condition does not improve with blood transfusions.I have not had major surgery in the last 4 weeks.I received targeted radiation for symptom relief within the last week.You have HIV or it's not known if you have HIV, but you will be tested for it before joining the study.You need to have a certain level of a type of white blood cell called neutrophils in your blood.Your platelet count is at least 50 billion per liter.I can swallow pills and follow the study's rules.I am not taking strong drugs that affect liver enzyme CYP3A4.You are allergic to any part of the medication AS-1763.I have previously been treated with specific noncovalent BTK inhibitors.Your hemoglobin level is 8 grams per deciliter or higher.I am 18 years old or older.My cancer is a type of B-cell malignancy and I've tried at least 2 treatments that didn't work or couldn't tolerate.My liver is working well.I do not have a condition that affects how my body absorbs medication.My condition has changed into a more aggressive form.I haven't taken proton pump inhibitors in the last 7 days.I am not taking strong medication for cancer resistance.I have not had a stem cell transplant or CAR-T therapy in the last 30 days.I can take care of myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion Cohort 1
- Group 2: Dose Expansion Cohort 2
- Group 3: 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.
Is recruitment for this research project ongoing?
"This research endeavour is open for recruitment, as evidenced by the details available on clinicaltrials.gov. The first posting dates back to May 1st 2023 and it was last updated 16 days later."
Answered by AI
Can individuals be exposed to any substantial harm through Dose Escalation?
"Taking into consideration the fact that this is a Phase 1 trial, with limited research to back claims of safety and efficacy, Dose Escalation's security rating has been estimated at a lowly 1 by our team."
Answered by AI
What is the aggregate figure of participants in this research?
"Affirmative. According to clinicaltrials.gov, this investigation has been actively seeking participants since May 1st 2023 and is currently still doing so with the last update being on May 16th 2023. 110 subjects must be enrolled at a single research centre for the trial's completion."
Answered by AI
What is the primary objective of this investigation?
"This clinical trial will be tracked over two dozen 28-day cycles, with the primary outcome being assessed by an independent safety committee. The secondary goals are to measure adverse events and any laboratory abnormalities arising from dose escalation or expansion of AS-1763 as well as its peak plasma concentration (Cmax)."
Answered by AI
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