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

NCT ID: NCT06716658

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-25
• Study Completion Date: 2028-11-15

Brief Summary

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.

Detailed Description

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.

Conditions

Lymphoma, T-Cell; NK-LGL Leukemia; T-LGL Leukemia; Cutaneous T Cell Lymphoma; Cutaneous T Cell Lymphoma (CTCL); Large Granular Lymphocyte Leukemia; Large Granular Lymphocytic Leukemia; Indolent T-Cell Lymphoproliferative Disorder of the Gastrointestinal Tract; Primary Cutaneous Acral CD8-Positive T-Cell Lymphoma; Mycosis Fungoides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JAK1 inhibitor

Golidocitnib 150mg QD orally

Group Type: EXPERIMENTAL

JAK1 Inhibitor

Intervention Type: DRUG

Golidocitnib 150mg 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

Interventions

JAK1 Inhibitor

Golidocitnib 150mg 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years, with no restrictions on gender;

2. 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;

3. The patient meets the criteria for appropriate therapeutic indications;

4. ECOG performance status of 0-2;

5. 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;

6. An expected survival time of at least 3 months;

7. 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;

8. 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;

9. The subject has not participated in any other clinical trial within 1 month prior to enrollment;

10. The subject agrees to and signs the informed consent form.

Exclusion Criteria

1. Subjects who have previously used any JAK inhibitors;

2. 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;

3. Subjects with active viral, bacterial, or fungal infections requiring treatment (e.g., pneumonia);

4. 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);

5. 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;

6. Subjects who have undergone autologous hematopoietic stem cell transplantation within 90 days prior to the first dose of study treatment;

7. Subjects with severe or uncontrolled cardiovascular diseases;

8. 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);

9. Pregnant or breastfeeding female subjects, or baseline positive pregnancy test results in women of childbearing potential;

10. Subjects with a history of other malignancies diagnosed or treated within the past 5 years;

11. Any other conditions that, in the investigator's opinion, render the subject unsuitable for participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin First Central Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Air Force Medicial University

OTHER

Sponsor Role: collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: collaborator

Tongji Hospital

OTHER

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Institute of Hematology & Blood Diseases Hospital

Tianjin, , China

Site Status: NOT_YET_RECRUITING

Countries

China

Central Contacts

Shuhua Yi, Doctor

Role: CONTACT

yishuhua@ihcams.ac.cn

86-22-23909106

Lugui Qiu, Doctor

Role: CONTACT

qiulg@ihcams.ac.cn

86-22-23909172

Facility Contacts

Shuhua Yi, Doctor

Role: primary

yishuhua@ihcams.ac.cn

86-22-23909106

Lugui Qiu, Doctor

Role: backup

qiulg@ihcams.ac.cn

86-22-23909172

Other Identifiers

IIT2024084

Identifier Type: -

Identifier Source: org_study_id