ClinicalTrials.gov record NCT06716658

JAK1 Inhibitor Golidocitnib for the Treatment of Relapsed/Refractory Indolent T/NK-cell Lymphomas

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

Exploratory Clinical Study of JAK1 Inhibitor Golidocitnib in the Treatment of Relapsed/Refractory Indolent T/NK-Cell Lymphomas：An Open, Prospective, Exploratory Clinical Trial

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 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationChina
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 2 study gives oral golidocitnib to adults with relapsed or refractory indolent T‑ or NK‑cell lymphomas. Participants take 150 mg once daily in 28‑day cycles for up to 24 cycles, with response checks each cycle early on then less often. The study measures tumor response and monitors safety.

What it is studying. The trial is testing whether giving the JAK1 inhibitor golidocitnib to people with relapsed or treatment‑resistant indolent T‑ or NK‑cell lymphomas is feasible and how tumors and patients respond. It also collects information about side effects and how long any responses last.

What the researchers hope to learn. To measure overall response rate (complete and partial responses) and to assess safety. Secondary goals include complete remission rate, duration of remission, time to response, progression‑free survival, overall survival, and disease control rate.

What this study is about

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

Indolent T/NK-cell lymphomas are a heterogeneous group of lymphoproliferative diseases originating from T/NK cells, characterized by slow growth and proliferation, but currently remain incurable. For indolent T/NK-cell lymphomas that are unresponsive to first-line treatment, there are few treatment options available and the prognosis is poor. This study is an open-label, prospective clinical trial aimed at evaluating the feasibility, efficacy, and safety of PI3K inhibitors in the treatment of relapsed/refractory indolent T/NK-cell lymphomas. Patients will be treated with Golidocitnib, with an expected overall response rate of 60% for JAK1 inhibitor Golidocitnib treatment.

Interventions being studied

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

Drug
  • JAK1 Inhibitor

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, with no restrictions on gender;
  • Histologically confirmed relapsed/refractory (R/R) indolent T/NK-cell; lymphoma that has failed at least one systemic therapy or is intolerant to such treatment and/or currently has no effective standard treatment options;
  • The patient meets the criteria for appropriate therapeutic indications;
  • ECOG performance status of 0-2;
  • Adequate organ function, defined as: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Blood urea nitrogen (BUN)/Urea and creatinine (Cr) ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF): < 450 ms for males, < 470 ms for females;
  • An expected survival time of at least 3 months;
  • Male and female subjects of childbearing potential must agree to use effective contraception throughout the study period and for 6 months after the last dose of the investigational drug;
  • A washout period of ≥ 4 weeks since receiving any prior antitumor therapies (including radiotherapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy) before participating in this study;
  • The subject has not participated in any other clinical trial within 1 month prior to enrollment;
  • The subject agrees to and signs the informed consent form.

Exclusion criteria

  • Subjects who have previously used any JAK inhibitors;
  • Subjects with clinical conditions such as dysphagia, malabsorption, or other chronic gastrointestinal diseases that may interfere with compliance and/or absorption of the study drug;
  • Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);
  • Subjects with HBV or HCV infections, defined as HBsAg and/or HBcAb positivity and HBV DNA copy number ≥ the upper limit of normal (ULN), or acute or chronic active hepatitis C (HCV antibody-positive);
  • Subjects with a history of immunodeficiency, including those who are HIV-positive, or those with other acquired or congenital immunodeficiency diseases, a history of organ transplantation, or a history of allogeneic bone marrow or hematopoietic stem cell transplantation;
  • Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;
  • Subjects with severe or uncontrolled cardiovascular diseases;
  • Subjects with severe concomitant diseases that pose a significant risk to patient safety or, in the investigator's judgment, may interfere with the completion of the study (e.g., uncontrolled hypertension, diabetes, or thyroid disorders);
  • Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;
  • Subjects with a history of other malignancies diagnosed or treated within the past 5 years;
  • Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.

Study description and what participation involves

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

Detailed description from the registry

Plan to enroll 48 patients with relapsed/refractory indolent T/NK-cell lymphomas; they will receive JAK1 inhibitor treatment (Golidocitnib150mg QD orally, with a 28-day cycle). Efficacy will be evaluated once per cycle during the first year, and once every two cycles thereafter. Treatment will continue for up to 24 cycles, or until disease progression, lack of response within the first 6 cycles, or the occurrence of intolerable toxicity, whichever occurs first.

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.

After screening and consent, participants will take Golidocitnib 150 mg once daily by mouth in 28‑day cycles. They will have clinic visits for efficacy and safety checks once per cycle in the first year and then every two cycles; treatment may continue for up to 24 cycles or stop earlier for disease progression, lack of response within the first 6 cycles, or intolerable toxicity. Screening and on‑study monitoring will include laboratory tests, heart‑function checks and pregnancy testing as needed, and ongoing safety assessments. Participants must follow contraception requirements and observe the required washout from prior anticancer treatments before starting.

How the study is structured. Phase 2, open‑label treatment trial with a single treatment group. All enrolled adults receive golidocitnib 150 mg by mouth once daily in 28‑day cycles. Responses are checked every cycle during the first year and then every two cycles; treatment can continue up to 24 cycles or stop for progression, lack of response in the first 6 cycles, or intolerable toxicity. No placebo or randomization is used.

Questions you could ask

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

  • The listed sites are in China. 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?

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Important dates

Study start
Dec 25, 2024
Primary completion
Nov 15, 2026 (estimated)
Study completion
Nov 15, 2028 (estimated)
Target enrollment
48 participants (estimated)
Last updated on registry
Nov 18, 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
Institute of Hematology & Blood Diseases Hospital, China
Collaborators
  • Tianjin First Central Hospital
  • The First Affiliated Hospital of Air Force Medicial University
  • The First Hospital of Jilin University
  • The First Affiliated Hospital of Nanchang University
  • Henan Cancer Hospital
  • Second Xiangya Hospital of Central South University
  • Tongji Hospital

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 (2)

  • Institute of Hematology & Blood Diseases Hospital, ChinaRecruiting

    Tianjin, Tianjin Municipality, 300020 · China

  • Institute of Hematology & Blood Diseases HospitalNot Yet Recruiting

    Tianjin, 300020 · China

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.
relapsed/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.
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.
standard treatment
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
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.
× ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
QTcF
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
investigational drug
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.
washout period
A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
informed consent form
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.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
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.

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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