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Tests treatment safety and results for B-cell Non-Hodgkin Lymphoma (B-NHL)
Official title An Early Clinical Study Evaluating the Safety and Efficacy of AcNK-Sup003 Cell Injection in the Treatment of Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
ClinicalTrials.gov ID: NCT06693973
What this study is testing
What is AcNK-Sup003 cell injection solution?
AcNK-Sup003 cell injection solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell non-hodgkin lymphoma (b-nhl).
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
- The purpose of this study is to determine whether AcNK-Sup003 cell injection is safe and effective in the treatment of elapsed or refractory B-cell non-Hodgkin's lymphoma.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Signed an informed consent form in writing and is able to comply with the visits and related procedures specified in the protocol.
- Age ≥18 years old, with an expected survival of more than 3 months.
- Confirmed by pathology to have CD20+ relapsed or refractory B-cell non-Hodgkin's lymphoma (according to the WHO 2016 lymphoma classification...
- Relapsed or refractory disease, defined by one or more of the following:
- Relapse, non-response, or progression after hematopoietic stem cell transplantation.
You likely can't join if
- Primary central nervous system lymphoma, or active central nervous system involvement or symptoms of central involvement.
- Accompanying active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, immune...
- Severe cardiovascular and cerebrovascular history, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree...
- Prolonged QT interval corrected by the Fridericia formula (QTcF), \>450 ms for males; \>470 ms for females.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events...
See the full eligibility criteria
Who can join
- Signed an informed consent form in writing and is able to comply with the visits and related procedures specified in the protocol.
- Age ≥18 years old, with an expected survival of more than 3 months.
- Confirmed by pathology to have CD20+ relapsed or refractory B-cell non-Hodgkin's lymphoma (according to the WHO 2016 lymphoma classification standards), including but not limited to diffuse large B-cell lymphoma...
- Relapsed or refractory disease, defined by one or more of the following:
- Relapse, non-response, or progression after hematopoietic stem cell transplantation.
- Disease stabilization but with a duration of ≤6 months after at least two cycles of second-line therapy (must have received CD20-targeted drugs [excluding CD20-negative tumors] and anthracycline drugs).
- Disease progression or relapse after second-line therapy (must have received CD20-targeted drugs [excluding CD20-negative tumors] and anthracycline drugs).
- ECOG performance status of 0-2.
- Males with fertility potential and women of childbearing age must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last administration of the study drug...
- Lymphoma must have at least one measurable lesion according to the Lugano 2014 criteria, that is, lymph node lesions with a long diameter \>15 mm or extranodal lesions with a long diameter \>10 mm, and positive FDG-PET...
- Hematological parameters (within 7 days before testing without transfusion or hematopoietic growth factor treatment): Hemoglobin (Hb) ≥80 g/L, Absolute Neutrophil Count (ANC) ≥1×10\^9/L, Platelet Count (PLT) ≥50×10\^9/L.
- Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN (people on prophylactic anticoagulant therapy must have an INR between 2.0-3.0).
- Hepatic, renal, and pulmonary function must meet the following requirements:
- Serum creatinine ≤1.5×ULN, or creatinine clearance ≥50 mL/min (estimated by the Cockcroft-Gault formula).
- Total bilirubin ≤1.5×ULN (≤3×ULN for people with liver lesions or Gilbert's syndrome).
- ALT and AST ≤3×ULN (≤5×ULN for people with liver lesions).
- Under indoor ventilation conditions and without oxygen supplementation, blood oxygen saturation is ≥92%.
What rules you out
- Primary central nervous system lymphoma, or active central nervous system involvement or symptoms of central involvement.
- Accompanying active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, immune thrombocytopenia, etc.), uncontrolled multi-cavity effusions; presence of...
- Severe cardiovascular and cerebrovascular history, including but not limited to:
- Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, etc.
- Prolonged QT interval corrected by the Fridericia formula (QTcF), \>450 ms for males; \>470 ms for females.
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurring within 6 months before screening.
- Heart failure with a New York Heart Association (NYHA) functional classification of ≥II or left ventricular ejection fraction (LVEF) \<50%.
- Clinically uncontrollable hypertension, with systolic blood pressure still ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg after standardized drug treatment.
- Received autologous hematopoietic stem cell transplantation or other autologous cell therapy products within 3 months before lymphodepletion; received allogeneic hematopoietic stem cell transplantation or other...
- Received anti-tumor drug treatment or participated in other treatment clinical studies within 4 weeks before lymphodepletion or within 5 half-lives (whichever is shorter), including but not limited to chemotherapy...
- Received live attenuated vaccine immunization or major surgery within 4 weeks before lymphodepletion, or people who require live attenuated vaccine immunization or major surgery during the study period.
- Requires long-term (≥3 days) systemic corticosteroid treatment during the study period (dose ≥10 mg/day prednisone or equivalent corticosteroids), excluding inhaled or topical use; as determined by the investigator.
- History of other malignant tumors (except for cervical carcinoma in situ, non-invasive basal cell or squamous cell skin cancer, or localized prostate cancer treated with radical therapy, and ductal carcinoma in situ...
- people with fungal, bacterial, viral, tuberculosis, or other infections requiring systemic anti-infective treatment within 14 days before lymphodepletion.
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with HBV DNA copies above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with HCV RNA copies above the...
- Has life-threatening hypersensitivity reactions or other intolerable conditions to the drugs used in the study, or severe allergic constitution.
- Pregnant or breastfeeding women.
- The investigator deems that the subject has other conditions that may affect compliance or is not suitable for participating in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 Wuhan, Hubei, 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.