Recruiting

Phase 1

AS-1763AS-1763 in Patients With Previously Treated CLL/SLL or Non-Hodgkin Lymphoma

Sponsor:

Carna Biosciences, Inc.

Code:

NCT05602363

Conditions

B-cell Malignancy

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Waldenstrom Macroglobulinemia

Mantle Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Docirbrutinib

Study Details

Brief 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.

Conditions

B-cell Malignancy

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Waldenstrom Macroglobulinemia

Mantle Cell Lymphoma

Study ID

NCT05602363

Start date

Aug 1, 2023

Status verified date

Jul, 2025

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Escalation

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).

experimental: Dose Expansion

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.

Interventions

Docirbrutinib

oral tablet, twice daily

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) ]
Overall response rate (ORR) as assessed by investigator [ Time Frame: Up to 24 cycles (1 cycle = 28 days) ]

Central Contacts and Locations

Central contacts

Akinori Arimura, PhD

650-636-4603 clinical_us@dd.carnabio.com

Locations

UC Irvine Health

Recruiting

Orange, California, United States, 92868

Contacts

Catherine Coombs, MD

714-456-8000 ucstudy@hs.uci.edu

Principal Investigator:

Catherine Coombs, MD

Mount Sinai Comprehensive Cancer Center

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Yvonne Enriquez

305-674-2625 yvonne.enriquez@msmc.com

Principal Investigator:

Jacqueline Barrientos, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Richard Corona

(813) 745-3465 richard.corona@moffitt.org

Principal Investigator:

Javier Pinilla-Ibarz, MD PhD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60661

Contacts

Study Cordinator

(312) 695 1301 cancer@northwestern.edu

Principal Investigator:

Shuo Ma, MD PhD

American Oncology Partners

Recruiting

Fort Wayne, Indiana, United States, 46804

Contacts

Phil Hutson

260-312-2219 phil.hutson@aoncology.com

Principal Investigator:

Sunil Babu, MD

University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Nikki M Glynn-Cunningham, MS

410-328-7996 nglynn@umm.edu

Principal Investigator:

Seung Tae Lee, MD PhD

University of Massachusetts Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

UMass Cancer Research Office

508-856-3216 cancer.research@umassmed.edu

Principal Investigator:

Andrew J Gillis-Smith, MD

Optum Medical Care PC

Recruiting

Westbury, New York, United States, 11590

Contacts

Jonathan Goldberg, MD

914-241-1050 jgoldberg@caremount.com

Principal Investigator:

Jonathan Goldberg, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Terri Lucas

919-681-6580 terri.lucas@duke.edu

Principal Investigator:

Danielle Brander, MD

Taylor Cancer Research Center

Recruiting

Maumee, Ohio, United States, 43537

Contacts

Nadine Nemunaitis

567-402-4501 nnemunaitis@tcrcpt.org

Principal Investigator:

John Nemunaitis, MD

Oncology Consultants

Recruiting

Houston, Texas, United States, 77030

Contacts

Laura Guerra, RN, CCRC

713-516-4968 lguerra@oncologyconsultants.com

Marisol Dominguez

832-333-1480 mdominguez@oncologyconsultants.com

Principal Investigator:

Julio A Peguero, MD

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Nitin Jain, MD

713-745-6080 njain@mdanderson.org

Principal Investigator:

Nitin Jain, MD

The Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53266

Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

414-805-8900 cccto@mcw.edu

Principal Investigator:

Nirav Shah, MD

More Information

Sponsor

Carna Biosciences, Inc.

Last update posted

Dec 10, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Carna Biosciences, Inc. on 2025-12-10.