Triple-Drug attack aims to beat rare lymphoma
NCT ID NCT07457177
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial tests a combination of three drugs—golidocitinib, pegaspargase, and an immunotherapy—as a first treatment for advanced NK T-cell lymphoma, a rare and aggressive cancer. The study will enroll 40 people who have not had prior therapy. The goal is to see if this combo can shrink tumors and improve survival, while monitoring for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Golidocitinib (a JAK inhibitor), pegaspargase (a chemotherapy drug), and an anti-PD-1 monoclonal antibody (an immunotherapy)
- What this could lead to
- If this works, it could offer a more effective first-line treatment for advanced NK T-cell lymphoma, potentially improving survival rates.
- What could go wrong
- This is an early phase 2 trial with only 40 participants, so results may not apply to everyone. The combination may cause side effects or fail to improve outcomes.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Voluntarily provides written informed consent (ICF) and agrees to comply with study procedures. 2. Histopathologically confirmed ENKTL per the 2022 WHO Classification of Lymphoid Neoplasms, with no prior systemic anti-lymphoma therapy. 3. At least one measurable or evaluable lesion per 2014 Lugano Classification: Measurable lesion: Lymph node ≥1.5 cm (long axis) × ≥1.0 cm (short axis); extranodal lesion ≥1.0 cm (long axis); if the only measurable lesion was previously irradiated, radiological progression after radiotherapy is required. Evaluable lesion: FDG-PET uptake higher than liver in lymph nodes or extranodal sites, consistent with lymphoma. 4. Age ≥18 years at ICF signing. 5. Estimated life expectancy ≥12 weeks. 6. ECOG performance status 0-2. Adequate organ and bone marrow function (without supportive care within 14 days): 7. Hematology: Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L (≥0.5×10⁹/L with bone marrow involvement); Platelet (PLT) ≥100×10⁹/L (≥50×10⁹/L with bone marrow involvement); Hemoglobin (HGB) ≥8.0 g/dL. Liver function: Total Bilirubin (TBIL) ≤1.5×ULN (≤3.0×ULN for Gilbert syndrome or liver involvement); Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×ULN (≤5.0×ULN for liver involvement). Renal function: Serum Creatinine (Cr) ≤1.5×ULN or Creatinine Clearance Rate (Ccr) ≥50 mL/min (Cockcroft-Gault method). Coagulation: International Normalized Ratio (INR) ≤1.5×ULN; Prothrombin Time (PT)/Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN (unless on anticoagulants with stable levels). Thyroid function: Thyroid Stimulating Hormone (TSH), Free Thyroxine (FT4), Free Triiodothyronine (FT3) within ±10% of normal range (non-autoimmune TSH abnormalities allowed). 8. Left Ventricular Ejection Fraction (LVEF) ≥50% by MUGA or echocardiogram. 9. Resolution of acute toxicities from prior therapies to ≤Grade 1 (CTCAE v5.0) or baseline; irreversible Grade 2 toxicities (e.g., neuropathy, alopecia) are allowed if not worsening. 10. Women of Childbearing Potential (WOCBP) must have negative serum pregnancy test within 7 days of first dose; WOCBP and male partners must use effective contraception from ICF signing to 6 months after last study drug dose. Exclusion Criteria: 1. Aggressive NK-cell leukemia or ENKTL in leukemic phase. 2. Concurrent hemophagocytic syndrome. 3. Lymphoma involvement of central nervous system (CNS) or meninges. 4. History of other malignancies within 5 years (except cured localized tumors: e.g., basal/squamous cell skin cancer, in situ prostate/cervical/breast cancer). 5. Prior therapy: Allogeneic hematopoietic stem cell transplantation (HSCT) within 5 years (allowed if \>5 years with no graft-versus-host disease). Autologous HSCT within 3 months. Prior JAK/STAT3 inhibitors. Concurrent use of strong CYP3A inducers/inhibitors (unable to discontinue 1 week before first dose). Concurrent vitamin K antagonists, antiplatelet agents, or anticoagulants (unable to discontinue 1 week before first dose). Systemic glucocorticoids or immunosuppressants within 14 days (local/ocular/inhaled/nasal glucocorticoids or short-term ≤7 days for prophylaxis allowed). Cytotoxic chemotherapy within 21 days. Systemic anti-tumor therapy (including mAbs, immunotherapy) within 4 weeks. Major surgery within 6 weeks or radiotherapy within 90 days. Toxin/isotope-antibody conjugates within 10 weeks. Investigational drugs within 30 days. Active infections: Active/latent tuberculosis (PPD positive with induration \>10 mm or radiological evidence). HIV infection. Active chronic hepatitis B (HBsAg positive with HBV DNA \>2500 copies/mL or 500 IU/mL) or hepatitis C (HCV RNA positive). HBV carriers with controlled HBV DNA and cured HCV are allowed; HBsAg-positive patients require monthly HBV DNA monitoring and prophylactic entecavir until 12 months after anti-tumor therapy. 6. Active viral infections (e.g., herpes zoster) or bacterial infections requiring IV/oral antimicrobials within 30 days (including pneumonia). 7. Active autoimmune diseases requiring systemic therapy within 2 years (allowed if inactive for 2 years; hormone replacement therapy for hypothyroidism/diabetes is allowed). 8. Uncontrolled cardiac disease: NYHA Class \>2 heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmias requiring treatment. 9. Prior interstitial lung disease (except radiation-induced asymptomatic disease). 10. Unresolved Grade \>1 AEs (except alopecia) from prior therapies. 11. Hypersensitivity to golidocitinib, pegaspargase, anti-PD-1 mAb, or excipients; history of Grade ≥3 hypersensitivity to mAbs or uncontrolled allergic asthma. 12. Refractory nausea/vomiting, chronic gastrointestinal disease, dysphagia, or prior bowel resection affecting drug absorption. 13. Pregnant or lactating women; unwilling to use contraception. 14. Psychiatric illness or inability to provide informed consent. 15. Investigator-determined unsuitability for study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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