Actively Recruiting
A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
Led by Carna Biosciences, Inc. · Updated on 2025-12-10
120
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating oral AS-1763 (docirbrutinib) in patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or B-cell non-Hodgkin lymphoma (NHL) who have not responded to or cannot tolerate at least two previous treatments. This Phase 1b, open-label, multi-center study aims to assess the safety, tolerance, and preliminary effectiveness of docirbrutinib in these patients. The study has two parts: dose escalation and dose expansion. In dose escalation, up to 27 patients will receive increasing doses of docirbrutinib tablets taken twice daily starting at 100 mg to find the maximum tolerated dose (MTD). The dose expansion part will enroll up to 48 CLL/SLL patients, 35 NHL patients, and 10 patients previously treated with a similar drug, pirtobrutinib. Patients will take docirbrutinib oral tablets twice daily for up to 24 cycles, each cycle lasting 28 days, with dose levels determined from the dose escalation results. Participants will be monitored throughout treatment for safety and response, including evaluations of side effects and blood tests. Assessments will continue for 24 cycles or until disease progression or unacceptable side effects. After treatment, patients will be followed for survival for up to two years. Researchers will measure dose-limiting toxicities, maximum tolerated dose, overall response rate, and other outcomes related to drug levels and disease status.
CONDITIONS
Brief Title
AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Provided written informed consent
- Histologically confirmed B-cell malignancy, including CLL/SLL, Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma, Marginal Zone Lymphoma, or Follicular Lymphoma
- For SLL, MCL, MZL, and FL patients: at least one radiographically measurable lesion
- Failed or intolerant to at least two prior lines of systemic therapy
- ECOG Performance Status of 0 to 2
- Adequate hematologic status (absolute neutrophil count �350.75 �d7 10�9/L, platelet count �350 �d7 10�9/L, hemoglobin �8 g/dL) without transfusion or growth factors
- Adequate liver function
- Adequate kidney function
- Ability to swallow tablets and comply with study requirements
- Male and female patients of reproductive potential must agree to use effective birth control
- Male patients must agree not to donate sperm during and for 6 months after the study
- Dose Expansion Cohort 3 patients must have prior treatment with pirtobrutinib for an approved indication
You will not qualify if you...
- Transformed disease (e.g., Richter's transformation) before or during screening
- Investigational or anticancer therapy within 5 half-lives before starting docirbrutinib, except for monoclonal antibody treatment stopped at least 4 weeks prior
- Current or planned investigational therapy during the study
- Requirement for therapeutic anticoagulation with warfarin
- Current use of strong CYP3A4 inhibitors or inducers
- Proton pump inhibitor use within 7 days before first docirbrutinib dose
- Current use of strong P-glycoprotein or BCRP inhibitors
- Refractory to transfusion support
- Major surgery within 4 weeks before starting docirbrutinib
- Radiotherapy for palliation within 7 days before first study dose
- Unresolved toxicities from prior therapy greater than Grade 2 except alopecia
- Stem cell transplant or CAR-T therapy within last 30 days
- Active second cancer unless in remission with life expectancy over 2 years
- Known central nervous system involvement by systemic lymphoma
- Active uncontrolled autoimmune cytopenia requiring new or increased therapy within 4 weeks before enrollment
- Significant uncontrolled heart or cardiovascular disease or recent myocardial infarction
- Prolonged QT interval on ECG during screening
- Active uncontrolled infections
- Positive for HIV or unknown HIV status without testing
- Significant malabsorption or other conditions affecting drug absorption
- Pregnant or breastfeeding
- Known allergy to docirbrutinib or its components
- Prior treatment with docirbrutinib
- Dose Escalation and Cohort 3 patients with prior noncovalent BTKi treatment except pirtobrutinib
- Dose Expansion Cohort 1 and 2 patients with prior noncovalent BTKi treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 cycles (each cycle = 28 days)
Participants self-administer oral docirbrutinib tablets twice daily for up to 24 cycles (each cycle is 28 days) to evaluate safety, tolerance, and efficacy.
Visits occur regularly during treatment for monitoring and assessments
Duration - 2 years
Participants are followed for survival status for 2 years after completing treatment or discontinuation.
Periodic survival status assessments
Trial Site Locations
Total: 13 locations
1
UC Irvine Health
Orange, California, United States, 92868
Actively Recruiting
2
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Actively Recruiting
3
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
4
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60661
Actively Recruiting
5
American Oncology Partners
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
6
University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
7
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Actively Recruiting
8
Optum Medical Care PC
Westbury, New York, United States, 11590
Actively Recruiting
9
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
10
Taylor Cancer Research Center
Maumee, Ohio, United States, 43537
Actively Recruiting
11
Oncology Consultants
Houston, Texas, United States, 77030
Actively Recruiting
12
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
The Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53266
Actively Recruiting
Research Team
A
Akinori Arimura, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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