Actively Recruiting
AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
Led by Carna Biosciences, Inc. · Updated on 2025-12-10
120
Participants Needed
13
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, multi-center Phase 1b clinical study of oral AS-1763 (docirbrutinib) in patients with CLL/SLL or B-cell NHL who have failed or are intolerant to ≥2 lines of systemic therapy.
CONDITIONS
Official 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 patients with SLL, MCL, MZL, and FL: at least one radiographically measurable lesion
- Failed or are intolerant to two or more prior systemic therapies
- ECOG Performance Status of 0 to 2
- Adequate blood counts without need for transfusion support or growth factors
- Adequate liver function
- Adequate kidney function
- Ability to swallow tablets and comply with study requirements
- Willingness to use effective birth control methods if of reproductive potential
- Male patients agree not to donate sperm during and for six months after the study
- For Dose Expansion Cohort 3: prior treatment with pirtobrutinib for an approved indication
You will not qualify if you...
- Transformed disease such as Richter's transformation before or during screening
- Use of investigational or anticancer therapy within five half-lives before starting docirbrutinib, except monoclonal antibody treatments stopped at least four weeks prior
- Current or planned treatment with investigational therapy concurrent with this study
- Need for therapeutic anticoagulation with warfarin
- Current use of strong CYP3A4 inhibitors or inducers
- Use of proton pump inhibitors within seven days before first dose
- Current use of strong P-glycoprotein or BCRP inhibitors
- Refractory to transfusion support
- Major surgery within four weeks before starting docirbrutinib
- Radiotherapy for palliation within seven days before first study dose
- Unresolved toxicities greater than Grade 2 except for hair loss
- History of stem cell transplant or CAR-T therapy within 30 days
- Active second cancer unless in remission with life expectancy over two years
- Known central nervous system lymphoma involvement
- Active uncontrolled autoimmune cytopenia requiring recent therapy changes
- Significant uncontrolled heart or cardiovascular disease or recent heart attack
- Active uncontrolled infections
- Positive HIV test
- Significant malabsorption or gastrointestinal conditions affecting drug absorption
- Pregnant or breastfeeding
- Known allergy to docirbrutinib or its ingredients
- Prior treatment with docirbrutinib
- For Dose Escalation and Cohort 3: prior treatment with noncovalent BTK inhibitors except pirtobrutinib
- For Dose Expansion Cohorts 1 and 2: prior treatment with any noncovalent BTK inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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