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New pill shows promise for Hard-to-Treat blood cancers

NCT ID NCT05602363

Disease control Sponsor: Carna Biosciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests an oral drug called AS-1763 in about 120 adults with chronic lymphocytic leukemia, small lymphocytic lymphoma, or other B-cell non-Hodgkin lymphomas who have already tried at least two other treatments. The study aims to find the safest dose and check if the drug can shrink tumors or control the disease. Participants take the pill twice daily, and researchers monitor side effects and how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AS-1763 (docirbrutinib) oral tablet
What this could lead to
If this trial succeeds, it could point toward a new treatment option for people with certain blood cancers who have run out of effective therapies.
What could go wrong
This is an early Phase 1b study with only 120 participants, so the drug may not prove safe or effective enough for wider use. Side effects and limited benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia B-cell neoplasm follicular lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma non-Hodgkin lymphoma Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell malignancy Chronic lymphocytic leukemia Follicular lymphoma Mantle cell lymphoma Marginal zone lymphoma Non-Hodgkin lymphoma Small lymphocytic lymphoma Waldenstrom macroglobulinemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • American Oncology Partners

    RECRUITING

    Fort Wayne, Indiana, 46804, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • Mount Sinai Comprehensive Cancer Center

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60661, United States

    Contact Email: •••••@•••••

  • Oncology Consultants

    RECRUITING

    Houston, Texas, 77030, United States

  • Optum Medical Care PC

    RECRUITING

    Westbury, New York, 11590, United States

  • Taylor Cancer Research Center

    RECRUITING

    Maumee, Ohio, 43537, United States

  • The Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53266, United States

  • UC Irvine Health

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • University of Maryland Medical Center - Greenebaum Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Massachusetts Memorial Medical Center

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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