Docirbrutinib for Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
This study is testing a new oral medication called docirbrutinib for people with certain types of B-cell cancers, including chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and non-Hodgkin lymphoma (NHL). You might be able to join if you are at least 18 years old, have one of these cancers, and your cancer has not responded to at least two previous treatments or you couldn't tolerate those treatments. The main goals of this study are to find a safe dose of docirbrutinib and to see how many patients respond to the treatment. The study is currently open, but the exact status is unclear. This drug works by targeting a specific protein (monoclonal antibody) involved in cancer growth.
- Study design
- This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll up to 120 participants and has two parts: a dose escalation part to find the right dose, and a dose expansion part to further evaluate safety and effectiveness.
- What's involved
- You would take docirbrutinib as an oral tablet twice daily. The study measures outcomes for up to 24 cycles, with each cycle lasting 28 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes for up to 24 cycles (each 28 days long) to assess the drug's effects.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05602363
AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentCarna Biosciences, Inc.
~120 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:Docirbrutinib
At a glance
Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD)
Measured over Up to 24 cycles (1 cycle = 28 days)
+1 more outcome measured
Conditions
Where it's being run
13 sites across 11 statesFlorida2
Texas2
California1
Illinois1
Indiana1
Maryland1
Massachusetts1
New York1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Age ≥18 years
Provided written informed consent
Histologically confirmed B-cell malignancy, including CLL/SLL, WM, MCL, MZL, or FL
Patients with SLL, MCL, MZL, and FL: at least 1 radiographically measurable lesion
Failed or are intolerant to ≥2 prior lines of systemic therapy
ECOG Performance Status 0 to 2
Adequate hematologic status (ie, absolute neutrophil count ≥0.75 × 10⁹/L, platelet count ≥50 × 10⁹/L, hemoglobin ≥8 g/dL) not requiring transfusion support or growth factors
Adequate hepatic function
Adequate renal function
Ability to swallow tablets and comply with study requirements for the duration of study participation
Male and female patients of reproductive potential: Willing to observe conventional and effective birth control methods
Male patients: agree not to donate sperm during and for 6 months after the study
Dose Expansion Cohort 3 patients: prior treatment with pirtobrutinib (Jaypirca) for an approved indication
Exclusion
Transformed disease (eg, Richter's transformation) prior to or during Screening
Investigational agent or anticancer therapy within 5 half-lives before the planned start of docirbrutinib, except therapeutic monoclonal antibody treatment which must be discontinued at least 4 weeks before the start of docirbrutinib
Current treatment with investigational therapy or planned investigational therapy which would be concurrent with this study
Requiring therapeutic anticoagulation with warfarin
Current treatment with certain strong CYP3A4 inhibitors or inducers
Treatment with proton pump inhibitors within 7 days before first dose of docirbrutinib
Current treatment with strong P-glycoprotein inhibitors or strong BCRP inhibitors
Refractory to transfusion support
Major surgery within 4 weeks before planned start of docirbrutinib
Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment
Any unresolved toxicities from prior therapy greater than NCI CTCAE Version 5.0 Grade 2 at the time of starting study treatment except for alopecia
History of allogeneic or autologous stem cell transplant or CAR-T therapy within the last 30 days
Active second malignancy unless in remission with life expectancy \>2 years
Known central nervous system (CNS) involvement by systemic lymphoma
Active uncontrolled autoimmune cytopenia (eg, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura) where new therapy introduced or concomitant therapy escalated within the 4 weeks before study enrollment is required to maintain adequate blood counts
Clinically significant, uncontrolled cardiac, cardiovascular disease or history of myocardial infarction within 6 months before planned start of docirbrutinib, or prolongation of the QT interval corrected for heart rate using Fridericia's Formula (QTcF) \>470 msec on at least 2 of 3 consecutive ECGs, and mean QTcF \>470 msec on all 3 ECGs, during Screening
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Positive for HIV. For patients with unknown HIV status, HIV testing will be performed at Screening
Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of docirbrutinib
Pregnant or lactating.
Known hypersensitivity to any component or excipient of docirbrutinib
Prior treatment with docirbrutinib
Dose Escalation and Cohort 3 patients: prior treatment with noncovalent BTKi except pirtobrutinib (Jaypirca)
Dose Expansion Cohort 1 and Cohort 2 patients: prior treatment with any noncovalent BTKi
What this trial measures
- Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD)Up to 24 cycles (1 cycle = 28 days)
Dose escalation
- Overall response rate (ORR) as assessed by investigatorUp to 24 cycles (1 cycle = 28 days)
Dose expansion