B-cell MalignancyPhase 1NCT05602363
AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma
A Phase 1 study testing Docirbrutinib in people with B-cell Malignancy and Chronic Lymphocytic Leukemia, run by Carna Biosciences, Inc. at 13 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Malignancy, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- What is being tested?
- Docirbrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 13 sitesUnited States
- Study dates
- 1 Aug 2023to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201
Nikki M Glynn-Cunningham, MS, 410-328-7996, nglynn@umm.edu
Seung Tae Lee, MD PhD
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60661
Study Cordinator, (312) 695 1301, cancer@northwestern.edu
Shuo Ma, MD PhD
- Recruiting
Duke University
Durham, North Carolina, 27705
Terri Lucas, 919-681-6580, terri.lucas@duke.edu
Danielle Brander, MD
- Recruiting
American Oncology Partners
Fort Wayne, Indiana, 46804
Phil Hutson, 260-312-2219, phil.hutson@aoncology.com
Sunil Babu, MD
- Recruiting
Oncology Consultants
Houston, Texas, 77030
Laura Guerra, RN, CCRC, 713-516-4968, lguerra@oncologyconsultants.com
Marisol Dominguez, 832-333-1480, mdominguez@oncologyconsultants.com
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Nitin Jain, MD, 713-745-6080, njain@mdanderson.org
Nitin Jain, MD
- Recruiting
Taylor Cancer Research Center
Maumee, Ohio, 43537
Nadine Nemunaitis, 567-402-4501, nnemunaitis@tcrcpt.org
John Nemunaitis, MD
- Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Yvonne Enriquez, 305-674-2625, yvonne.enriquez@msmc.com
Jacqueline Barrientos, MD
- Recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53266
Medical College of Wisconsin Cancer Center Clinical Trials Office, 414-805-8900, cccto@mcw.edu
Nirav Shah, MD
- Recruiting
UC Irvine Health
Orange, California, 92868
Catherine Coombs, MD, 714-456-8000, ucstudy@hs.uci.edu
Catherine Coombs, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Richard Corona, (813) 745-3465, richard.corona@moffitt.org
Javier Pinilla-Ibarz, MD PhD
- Recruiting
Optum Medical Care PC
Westbury, New York, 11590
Jonathan Goldberg, MD, 914-241-1050 ext. 3512, jgoldberg@caremount.com
Jonathan Goldberg, MD
- Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
UMass Cancer Research Office, 508-856-3216, cancer.research@umassmed.edu
Andrew J Gillis-Smith, MD
About this study
Official title: A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
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.
Read the detailed description
This study consists of 2 parts.
Dose escalation part will enroll up to 27 patients to evaluate safety profile and tolerance of docirbrutinib using 3+3 design. The starting dose of docirbrutinib in oral tablet form is 100 mg twice daily (200 mg/day). Dose escalation will continue up to the planned maximum dose level or until the maximum tolerated dose (MTD) has been identified.
Dose expansion part will enroll up to 48 CLL/SLL patients (Cohort 1), up to 35 NHL patients (Cohort 2), and up to 10 patients with prior pirtobrutinib treatment for an approved indication (Cohort 3). The first 30 patients in each Cohort 1 or 2 will be allocated to three dose levels (n=10 at each dose level) which will be selected based on the data from dose escalation. Preliminary efficacy and safety data from the first 30 patients in one of cohorts will be used to identify the provisional recommended Phase 2 dose (RP2D) level. Thereafter, up to a further 18 patients for Cohort 1 and up to a further 5 patients for Cohort 2 will be enrolled and allocated to the provisional RP2D level. Cohort 3 will be enrolled in parallel with Cohorts 1 and 2 and will be allocated to up to two dose levels (either n=10 at a single dose level or n=5 at each of 2 dose levels).
Study assessments will continue for 24 cycles (1 cycle = 28 days) or until disease progression, occurrence of unacceptable toxicity, or discontinuation because of other reasons. Patients will then be followed for survival status for a further 2 years.
RP2D will be determined based on all the data generated in the study.
- Conditions
- B-cell Malignancy, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma, Marginal Zone Lymphoma
- Being tested
- Docirbrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Waldenstrom Macroglobulinemia, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocirbrutinibDrug
Also called AS-1763
oral tablet, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Dose escalation (3+3 design) and determination of MTD and DLTs
CLL/SLL or B-cell NHL patients will self-administer docirbrutinib oral tablet at multiple dose levels twice daily for 24 cycles (1 cycle = 28 days). Receives: Drug: Docirbrutinib |
| Dose Expansion | Experimental | Cohort 1: CLL/SLL patients, Cohort 2: B-cell NHL patients, Cohort 3: CLL/SLL or B-cell NHL patients with prior treatment with pirtobrutinib (Jaypirca) for an approved indication
Patients will self-administer docirbrutinib oral tablet for 24 cycles (1 cycle = 28 days). Dose levels will be determined based on the result of dose escalation part. Receives: Drug: Docirbrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD)
Dose escalation
Measured: Up to 24 cycles (1 cycle = 28 days)
Overall response rate (ORR) as assessed by investigator
Dose expansion
Measured: Up to 24 cycles (1 cycle = 28 days)
Secondary outcomes (9)
Number of patients with adverse events (AEs) and clinical laboratory abnormalities
Dose escalation, dose expansion
Measured: Up to 24 cycles (1 cycle = 28 days)
Area under the plasma concentration versus time curve (AUC) of docirbrutinib
Dose escalation, dose expansion
Measured: Up to 24 cycles (1 cycle = 28 days)
Peak Plasma Concentration (Cmax) of docirbrutinib
Dose escalation, dose expansion
Measured: Up to 24 cycles (1 cycle = 28 days)
Time to maximum plasma concentration (tmax) of docirbrutinib
Dose escalation, dose expansion
Measured: Up to 24 cycles (1 cycle = 28 days)
ORR as assessed by investigator
Dose escalation
Measured: Up to 24 cycles (1 cycle = 28 days)
Best overall response as assessed by investigator
Dose expansion
Measured: Up to 24 cycles (1 cycle = 28 days)
Duration of response as assessed by investigator
Dose expansion
Measured: Up to 24 cycles (1 cycle = 28 days)
Progression free survival as assessed by investigator
Dose expansion
Measured: Up to 24 cycles (1 cycle = 28 days)
Overall survival
Dose expansion
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Aug 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carna Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602363
- Sponsor's protocol ID
- C1763102
- Status last verified
- Jul 2025
- First submitted
- 24 Oct 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT05602363
- Acronym / sponsor ID
- C1763102
- Conditions
- B-cell Malignancy, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma, Marginal Zone Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Carna Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of 2 parts.
Dose escalation part will enroll up to 27 patients to evaluate safety profile and tolerance of docirbrutinib using 3+3 design. The starting dose of docirbrutinib in oral tablet form is 100 mg twice daily (200 mg/day). Dose escalation will continue up to the planned maximum dose level or until the maximum tolerated dose (MTD) has been identified.
Dose expansion part will enroll up to 48 CLL/SLL patients (Cohort 1), up to 35 NHL patients (Cohort 2), and up to 10 patients with prior pirtobrutinib treatment for an approved indication (Cohort 3). The first 30 patients in each Cohort 1 or 2 will be allocated to three dose levels (n=10 at each dose level) which will be selected based on the data from dose escalation. Preliminary efficacy and safety data from the first 30 patients in one of cohorts will be used to identify the provisional recommended Phase 2 dose (RP2D) level. Thereafter, up to a further 18 patients for Cohort 1 and up to a further 5 patients for Cohort 2 will be enrolled and allocated to the provisional RP2D level. Cohort 3 will be enrolled in parallel with Cohorts 1 and 2 and will be allocated to up to two dose levels (either n=10 at a single dose level or n=5 at each of 2 dose levels).
Study assessments will continue for 24 cycles (1 cycle = 28 days) or until disease progression, occurrence of unacceptable toxicity, or discontinuation because of other reasons. Patients will then be followed for survival status for a further 2 years.
RP2D will be determined based on all the data generated in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: DocirbrutinibDose escalation (3+3 design) and determination of MTD and DLTs CLL/SLL or B-cell NHL patients will self-administer docirbrutinib oral tablet at multiple dose levels twice daily for 24 cycles (1 cycle = 28 days). |
| Dose Expansion | Experimental | Drug: DocirbrutinibCohort 1: CLL/SLL patients, Cohort 2: B-cell NHL patients, Cohort 3: CLL/SLL or B-cell NHL patients with prior treatment with pirtobrutinib (Jaypirca) for an approved indication Patients will self-administer docirbrutinib oral tablet for 24 cycles (1 cycle = 28 days). Dose levels will be determined based on the result of dose escalation part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocirbrutinibAlso: AS-1763oral tablet, twice daily | Drug | Dose Escalation, Dose Expansion |
Primary outcome
Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD)
Time frame: Up to 24 cycles (1 cycle = 28 days)
Dose escalation
Overall response rate (ORR) as assessed by investigator
Time frame: Up to 24 cycles (1 cycle = 28 days)
Dose expansion
9 secondary outcomes
Number of patients with adverse events (AEs) and clinical laboratory abnormalities
Time frame: Up to 24 cycles (1 cycle = 28 days)
Area under the plasma concentration versus time curve (AUC) of docirbrutinib
Time frame: Up to 24 cycles (1 cycle = 28 days)
Peak Plasma Concentration (Cmax) of docirbrutinib
Time frame: Up to 24 cycles (1 cycle = 28 days)
Time to maximum plasma concentration (tmax) of docirbrutinib
Time frame: Up to 24 cycles (1 cycle = 28 days)
ORR as assessed by investigator
Time frame: Up to 24 cycles (1 cycle = 28 days)
Best overall response as assessed by investigator
Time frame: Up to 24 cycles (1 cycle = 28 days)
Duration of response as assessed by investigator
Time frame: Up to 24 cycles (1 cycle = 28 days)
Progression free survival as assessed by investigator
Time frame: Up to 24 cycles (1 cycle = 28 days)
Overall survival
Time frame: Up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docirbrutinib in people with B-cell Malignancy and Chronic Lymphocytic Leukemia, run by Carna Biosciences, Inc. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Akinori Arimura, PhD (650-636-4603, clinical_us@dd.carnabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with dose limiting toxicities (DLTs) and determination of maximum tolerated dose (MTD) (time frame: Up to 24 cycles (1 cycle = 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.