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Tests treatment safety and results for NK/T-cell Lymphoma
Official title Safety and Efficacy of Anti-EBV Autologous TCR-T Cell Injection in Relapsed/Refractory EBV-Positive Lymphoma
ClinicalTrials.gov ID: NCT07162012
What this study is testing
What is EBV TCR-T?
EBV TCR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nk/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
- This study will test whether anti-EBV autologous TCR-T cell injection is safe and effective for patients with relapsed or refractory EBV-positive lymphoma who have HLA-A11:01. Researchers will look at safety, tolerability, and the maximum tolerated dose or recommended dose for future studies.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Age 18-70 years, male or female.
- HLA genotype at locus A is 11:01.
- Disease diagnosis and status:
- Histologically or cytologically confirmed EBV-positive lymphoma (tumor tissue must be EBER-positive as confirmed by in situ hybridization [ISH] or...
- Disease types include but are not limited to: NK/T-cell lymphoma (NK/TCL); Peripheral T-cell lymphoma (PTCL); Other types.
You likely can't join if
- people meeting any of the following conditions will not be eligible for enrollment:
- History of other malignancies, except for:
- Basal cell carcinoma of the skin;
- Squamous cell carcinoma of the skin;
- Superficial bladder cancer;
- Carcinoma in situ of the cervix;
See the full eligibility criteria
Who can join
- Age 18-70 years, male or female.
- HLA genotype at locus A is 11:01.
- Disease diagnosis and status:
- Histologically or cytologically confirmed EBV-positive lymphoma (tumor tissue must be EBER-positive as confirmed by in situ hybridization [ISH] or fluorescence in situ hybridization [FISH]), with peripheral blood EBV...
- Disease types include but are not limited to: NK/T-cell lymphoma (NK/TCL); Peripheral T-cell lymphoma (PTCL); Other types.
- Definition of relapse: appearance of new lesions at the primary site or other sites after achieving complete remission (CR).
- Definition of refractory disease (meeting any of the following): No partial remission (PR) after ≥4 cycles of standard therapy; No complete remission (CR) after ≥6 cycles of therapy; Failure to achieve CR after...
- Prior treatment requirements: a) For relapsed/refractory PTCL or NK/TCL, patients must have received at least one prior line of systemic therapy. For relapsed/refractory NK/TCL, patients must have received an...
- Measurable disease: At least one measurable lesion according to the 2014 Lymphoma Response Evaluation Criteria:
- Nodal lesions: longest diameter \>15 mm on contrast-enhanced CT, MRI, or PET-CT;
- Extranodal lesions: longest diameter \>10 mm. For patients with bone-marrow-only involvement who have no measurable lesions on imaging, the presence of ≥5% lymphoma cells in bone marrow biopsy or flow cytometry can be...
- Adequate organ function, defined as:
- Hematologic: absolute neutrophil count ≥1×10⁹/L; hemoglobin ≥70 g/L; platelet count ≥50×10⁹/L;
- Hepatic: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × the upper limit of normal (ULN), and total bilirubin (TBIL) ≤ 1.5 × ULN (except when liver function abnormalities are attributable to...
- Renal: serum creatinine ≤1.5× ULN;
- Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
- Coagulation: fibrinogen ≥1.0 g/L; activated partial thromboplastin time (APTT) ≤1.5× ULN; prothrombin time (PT) ≤1.5× ULN.
- Expected survival \>3 months.
- ECOG performance status \<3.
- Contraception requirements:
- No pregnancy planned during the treatment period;
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for 4 months after the end of treatment.
- Willingness to participate in the study, ability to sign informed consent, comply with the study protocol, and availability of peripheral venous access for lymphocyte collection.
What rules you out
- people meeting any of the following conditions will not be eligible for enrollment:
- History of other malignancies, except for:
- Basal cell carcinoma of the skin;
- Squamous cell carcinoma of the skin;
- Superficial bladder cancer;
- Carcinoma in situ of the cervix;
- Gastrointestinal mucosal carcinoma in situ;
- Other malignancies considered acceptable by the investigator (must have received curative treatment with no recurrence within the past 5 years).
- Recent anti-tumor therapy: less than 4 weeks since last anti-cancer therapy (radiotherapy, chemotherapy, targeted therapy, immunotherapy, or local therapy), or less than 2 weeks since palliative radiotherapy.
- Pregnant or breastfeeding women.
- Presence of severe medical conditions such as intracranial hypertension, impaired consciousness, respiratory failure, or disseminated intravascular coagulation (DIC).
- Severe organ dysfunction, including: NYHA class IV cardiac function; Child-Pugh class C liver function; Creatinine clearance \<60 mL/min (by Cockcroft-Gault formula); Baseline oxygen saturation \<92%.
- Known active infections or positive screening results for:
- Hepatitis B virus (HBV): HBsAg positive, or HBcAb positive with HBV-DNA above the detection limit of the study center;
- Hepatitis C virus (HCV): HCV antibody positive and HCV RNA ≥ upper limit of normal (ULN);
- Human immunodeficiency virus (HIV) or Treponema pallidum (syphilis) antibody positive;
- Active tuberculosis (TB) (must be excluded by chest X-ray, sputum test, and clinical symptoms) or history of active TB;
- Severe acute or chronic infections requiring systemic treatment.
- Active central nervous system (CNS) disease (e.g., tumor metastasis, infection, demyelinating disease), including untreated lesions, progressive disease on imaging or symptoms requiring urgent intervention, or requiring...
- Receiving systemic corticosteroid therapy prior to screening and judged by the investigator to require long-term systemic corticosteroid treatment during the study (excluding inhaled or topical use); or receiving...
- Presence of graft-versus-host disease (GVHD), defined as grade ≥2 acute GVHD or moderate/severe chronic GVHD, or current use of immunosuppressive therapy.
- History of severe allergic reactions to drugs or excipients required in this study, or history of allergy to tocilizumab.
- Any condition that, in the opinion of the investigator, makes the subject unsuitable for study participation.
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 to 70 years. 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.