ClinicalTrials.gov record NCT05602363

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Phase 1b Study of Oral AS-1763 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This open-label Phase 1b study evaluates oral AS-1763 (docirbrutinib) in people with previously treated CLL/SLL or other B‑cell non-Hodgkin lymphomas who have failed or are intolerant to at least two prior systemic therapies. It begins with a dose-escalation 3+3 phase to find a maximum tolerated dose, then expands into cohorts for CLL/SLL, NHL, and a cohort with prior pirtobrutinib treatment. Treatment is given as oral tablets twice daily for up to 24 cycles (28-day cycles), with survival follow-up for two years.

What it is studying. The study is testing the safety, tolerability, recommended Phase 2 dose, drug levels in the blood, and early signs of anti-cancer effect of oral docirbrutinib (AS-1763) in people with previously treated CLL/SLL and various B‑cell non-Hodgkin lymphomas.

What the researchers hope to learn. To define safety and the maximum tolerated or recommended Phase 2 dose of docirbrutinib, to measure drug levels in the blood (pharmacokinetics), and to collect preliminary measures of anti-cancer activity such as overall response rate, duration of response, progression-free survival, and overall survival.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Docirbrutinib

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take oral docirbrutinib tablets twice daily and follow the study schedule for up to 24 cycles (1 cycle = 28 days) or until disease progression, unacceptable toxicity, or other discontinuation. The study includes a dose‑finding (3+3) escalation part to identify a tolerated dose and a dose‑expansion part with disease-specific cohorts; dose levels for expansion are chosen from escalation results. During treatment participants will have regular assessments to monitor safety and disease response and the study will measure drug levels; after stopping treatment they will be followed for survival for up to 2 years. The registry record does not list full visit schedules or specific tests (for example scans, biopsies, or exact timing of blood sampling); request the study protocol or contact the study team for complete procedural details and participant support information.

How the study is structured. This is an interventional, non-randomized, open-label Phase 1 study. First, up to 27 patients enter a 3+3 dose-escalation phase to identify dose-limiting toxicities and the maximum tolerated dose. Then there is a dose-expansion phase with planned cohorts: up to 48 CLL/SLL patients, up to 35 NHL patients, and up to 10 patients with prior pirtobrutinib; the expansion uses dose levels chosen from the escalation data and may enroll additional patients at a provisional recommended Phase 2 dose. Participants take oral docirbrutinib tablets twice daily for up to 24 cycles (1 cycle = 28 days) and are followed for survival for an additional two years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Aug 1, 2023
Primary completion
September 2027 (estimated)
Study completion
September 2027 (estimated)
Target enrollment
120 participants (estimated)
Last updated on registry
Dec 10, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Carna Biosciences, Inc.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (13)

Terms used on this page · explanations by MedicalUpdates.ai

open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Histologically confirmed
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
prior lines
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
ECOG Performance Status
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
absolute neutrophil count
The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
Cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
during Screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Investigational agent
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
Refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
autologous stem cell transplant
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
CAR-T
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
concomitant therapy
Other medicines a participant takes during the study. Some must be reported; some are restricted.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
QTcF
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
Dose Escalation
Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
maximum tolerated dose
The highest dose found in a dose-escalation study that can be given without too many dose-limiting side effects.
recommended Phase 2 dose
The dose chosen at the end of a phase 1 study for testing in later studies, based on safety and other measurements.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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