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New treatment option for Natural Killer/T-cell Lymphoma
Official title PD-1 Antibody-based Therapy With Concurrent RT for Early-stage NKTCL
ClinicalTrials.gov ID: NCT07380984
What this study is testing
What is PD-1 antibody?
PD-1 antibody is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for natural killer/t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Natural killer/T-cell lymphoma (nasal type) is a mature T/NK-cell lymphoma closely associated with Epstein-Barr virus (EBV), with a high prevalence among populations in Asia and South America. It primarily occurs at extranodal sites, including the nasal/paranasal regions, skin, gastrointestinal tract, and other organs.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The subject has histopathologically confirmed extranodal NK/T-cell lymphoma, nasal type (according to the 2022 WHO classification).
- No prior history of anti-lymphoma therapy.
- Age ≥ 18 years.
- Life expectancy \> 3 months.
- Ann Arbor stage I-II.
You likely can't join if
- Advanced-stage disease (Ann Arbor Stage III-IV).
- Nonnasal-type NKTCL.
- A history of autoimmune disease requiring systemic treatment (i.e., with disease-modifying antirheumatic drugs, corticosteroids, or...
- A history of other invasive malignancies within the past 3 years that has not been treated with curative intent or is currently receiving anticancer...
- A history of (non-infectious) pneumonia requiring corticosteroid therapy; or clinical evidence of interstitial lung disease or active, non-infectious...
- Active infections requiring systemic treatment, including:
See the full eligibility criteria
- The subject has histopathologically confirmed extranodal NK/T-cell lymphoma, nasal type (according to the 2022 WHO classification).
- No prior history of anti-lymphoma therapy.
- Age ≥ 18 years.
- Life expectancy \> 3 months.
- Ann Arbor stage I-II.
- At least one measurable/evaluable disease site confirmed by diagnostic biopsy prior to the initiation of treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Signed informed consent form (ICF).
- Willingness and ability to comply with the study protocol.
- Sufficient bone marrow, hepatic, and renal function, defined as:
- Absolute neutrophil count (ANC) \> 1,000/μL
- Platelet count \> 50,000/μL
- Hemoglobin \> 9 g/dL
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 3× upper limit of normal (ULN)
- Serum total bilirubin \< 1.5 × ULN (patients with Gilbert's syndrome are eligible)
- Serum creatinine \ 50 mL/min
- Availability of tumor tissue samples (preferably fresh tissue; archived tissue samples are acceptable).
- For women of childbearing potential, agreement to use adequate contraception to avoid pregnancy during the study treatment period.
- For male, agreement to remain abstinent or use a barrier method of contraception.
- Advanced-stage disease (Ann Arbor Stage III-IV).
- Nonnasal-type NKTCL.
- A history of autoimmune disease requiring systemic treatment (i.e., with disease-modifying antirheumatic drugs, corticosteroids, or immunosuppressants) within the past 2 years, including but not limited to myasthenia...
- A history of other invasive malignancies within the past 3 years that has not been treated with curative intent or is currently receiving anticancer therapy (including hormonal therapy for breast or prostate cancer).
- A history of (non-infectious) pneumonia requiring corticosteroid therapy; or clinical evidence of interstitial lung disease or active, non-infectious pneumonia.
- Active infections requiring systemic treatment, including:
- A known history of active tuberculosis;
- Positive results for HBsAg, HCV, or HIV; HBV seropositivity is permitted only if HBV DNA \< 1000 IU/mL;
- Active viral infections other than hepatitis B and C (e.g., herpes zoster).
- Severe cardiovascular disease, including myocardial infarction, unstable arrhythmia, or unstable angina occurring within the past 3 months.
- Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents.
- Administration of live-attenuated vaccines within 4 weeks prior to the initiation of study treatment; patients are prohibited from receiving live-attenuated vaccines during the study period, including influenza vaccines.
- Use of systemic immunosuppressive agents within 2 weeks prior to the initiation of study treatment, or planned use of such agents during the study period, including cyclophosphamide, azathioprine, methotrexate...
- Evidence of central nervous system involvement.
- A history of allogeneic tissue/solid organ transplantation.
- A history of severe hypersensitivity reactions (Grade ≥ 3) to PD-1 monoclonal antibodies and/or their excipients, or to gorlitinib and/or its excipients.
- Any other factors judged by the investigator to potentially affect compliance with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.