Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunityBio, Inc.
About this trial
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. The initial 3 subjects will be sequentially enrolled in a staggered fashion, with a 7 day interval between each subject to enable the capture and monitoring of any acute and subacute toxicities.
Eligibility criteria
Qualifiers
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.
Have active disease after ≥ 2 lines of cytotoxic chemotherapy.
Have received rituximab or another anti-CD20 antibody.
Disqualifiers
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 requiring steroid therapy defined as > 20 mg of prednisone or equivalent daily.
Trial design
Treatments tested in this trial
- N803
- CD19t-haNK suspension
- Cyclophosphamide
- Fludarabine
- Rituximab
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov