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New treatment option for Non Hodgkin's Lymphoma Refractory/Relapsed
Official title Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma
ClinicalTrials.gov ID: NCT05618925
What this study is testing
What is N803?
N803 is an investigational medicine, being studied as a potential treatment for non hodgkin's lymphoma refractory/relapsed.
Also referred to as Anktiva.
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
- Open-label, Phase 1 Study of CD19 t-haNK as a Single Agent and in Combination With an IL-15 Superagonist (N-803) and Rituximab in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma. Up to 20 subjects will be enrolled and randomized 1:1 to 1 of 2 cohorts, as outlined below.
- 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
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee...
- Histologically documented CD19- and CD20-positive B-cell NHL with the following specific criteria:
- Have active disease after ≥ 2 lines of cytotoxic chemotherapy.
- Have received rituximab or another anti-CD20 antibody.
You likely can't join if
- Known hypersensitivity to any component of the study medication(s), including anaphylactic reaction to sulfur-containing medications.
- Known allergy to albumin (human) or dimethyl sulfoxide (DMSO).
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the...
- History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's...
- History of allogeneic hematopoietic stem-cell transplantation (HSCT) or allogeneic chimeric antigen receptor (CAR) T therapy within 6 months of day 1...
- Anti-CD19 or anti-CD20 antibody treatment within 4 weeks of cell infusion.
See the full eligibility criteria
Who can join
- Age ≥ 18 years old.
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Histologically documented CD19- and CD20-positive B-cell NHL with the following specific criteria:
- Have active disease after ≥ 2 lines of cytotoxic chemotherapy.
- Have received rituximab or another anti-CD20 antibody.
- Have either failed autologous transplant or are ineligible to receive autologous transplant.
- Have measurable disease by Lugano classification documented within 8 weeks of the time of consent, defined as nodal lesions \> 15 mm in the long axis or extranodal lesions \> 10 mm in long and short axis, or bone marrow...
- Have CD19- and CD20-positive disease on most recent biopsy performed (a repeat biopsy is not mandatory for this study except as noted below). A minimum of 5% CD19 and CD20 positivity by immunohistochemistry or flow...
- History of central nervous system (CNS) involvement with cerebral spinal fluid (CSF) analysis following magnetic resonance imaging (MRI) brain and lumbar puncture showing no evidence of CNS involvement by cytology and...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Expected survival \> 12 weeks.
- Willing and able to have central line placed for study drug infusions.
- Stated willingness to comply with study procedures.
- Able to attend required study visits and return for adequate follow-up, as required by this protocol.
- Agreement to practice effective contraception for female people of child-bearing potential and nonsterile males. Female people of child-bearing potential must agree to use effective contraception while on study and for...
What rules you out
- Known hypersensitivity to any component of the study medication(s), including anaphylactic reaction to sulfur-containing medications.
- Known allergy to albumin (human) or dimethyl sulfoxide (DMSO).
- Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the subject at high risk for treatment-related complications.
- History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura...
- History of allogeneic hematopoietic stem-cell transplantation (HSCT) or allogeneic chimeric antigen receptor (CAR) T therapy within 6 months of day 1 or require ongoing systemic graft versus host disease (GvHD) therapy.
- Anti-CD19 or anti-CD20 antibody treatment within 4 weeks of cell infusion.
- Live vaccine \< 6 weeks prior to starting lymphodepleting chemotherapy.
- History of receiving allograft organ transplant requiring immunosuppression.
- people post solid organ transplant who develop high grade lymphomas or leukemias.
- Known lymphomatous involvement of the CNS, including the parenchyma or leptomeninges.
- Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).
- History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
- Inadequate organ function, evidenced by the following laboratory results:
- ANC \< 1000 cells/mm3.
- Platelet count \< 100,000 cells/mm3.
- Total bilirubin ≥ 1.5 × the upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome or indirect hyperbilirubinemia).
- Aspartate aminotransferase (AST [SGOT])/ALT (SGPT) ≥ 2.5 × ULN.
- Alkaline phosphatase (ALP) levels ≥ 2.5 × ULN (or ≥ 5 × ULN in people with bone metastases).
- Serum creatinine \> 1.6 mg/dL. Each study site should use its institutional ULN to determine eligibility.
- Uncontrolled hypertension (systolic \> 160 mm Hg and/or diastolic \> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial infarction within 6 months...
- Current chronic daily treatment (continuous for \> 3 months) with systemic corticosteroids (dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. Short-term steroid use to prevent...
- Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.
- History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \< 500 cells/μL..
- Chronic carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive. NOTE: people who have a history of HIV/HBV or who are seropositive will require testing for...
- Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
- Women who are pregnant or breastfeeding. A negative urine or serum pregnancy test in women of child bearing potential is required at screening and again within 48 hours prior to lymphodepleting chemotherapy
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Tyler, Texas, United States
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 Newport Beach, California, United States; Tyler, Texas, United States. 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.