Study for Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorImmunityBio, Inc.
About this trial
Open Label, Phase 1 study of CD19 t-haNK as a single agent and combination with rituximab in subjects with selected CD19+ and CD20+ R/R B-cell non-Hodgkin Lymphoma( NHL).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old.
Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.
Have completed ≥ 2 lines of cytotoxic chemotherapy.
Have received rituximab or another anti-CD20 antibody.
Disqualifiers
Histologically documented primary CNS lymphoma, CLL, Burkitt, or Burkitt-like lymphoma.
Known hypersensitivity to sulfa-containing study medication(s), including anaphylactic reaction to sulfa-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 participant at high risk for treatment related complications.
Trial design
Design model
Single group
Treatments tested in this trial
CD19 t-haNK
Biological/VaccineCD19t-haNK erived from the parental NK-92 (aNK) cell line, CD19 t-haNK is a human, allogeneic, NK cell line that has been engineered to express a CAR targeting CD19. Similar to the haNK cell line, CD19 t haNK has also been engineered to produce endoplasmic reticulum-retained IL 2 and the high-affinity (158V) variant of the Fcγ receptor (FcγRIIIa/CD16a), and thereby has enhanced CD16-targeted ADCC capabilities. CD19 t-haNK is similar to PD L1 t-haNK, differing only in the CAR that is expressed (CD19 vs PD-L1). Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD and has a binding affinity for the CD20 antigen of approximately 8.0 nM.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: CD19 t-haNK with RituximabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall safety evaluation in combining CD19 t haNK as a single agent with rituximab
Safety will be assessed for all participants and will include vital signs, physical examinations, clinical labs (hematology, chemistry panel, pregnancy tests), cytokine levels, electrocardiograms, neurological assessments, and the incidence and severity of adverse events (AEs) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. All participants will receive follow-up phone calls 6 hours (± 1 hour) and 24 hours (± 2 hours) post infusion for AE collection during Cycle 1
Time frame
30 days2
Incidence of treatment-emergent AEs (TEAEs) and serious AEs (SAEs) graded using the National Cancer Institute (NCI) CTCAE Version 5.0.Clinically important changes in safety laboratory tests and vital signs.
The incidence of TEAEs and SAEs will be presented by System Organ Class and Medical Dictionary for Regulatory Activities (MedDRA) preferred term. All AEs will be graded using CTCAE Version 5.0 except for CRS and ICANS, which will be graded using ICE score. The incidence of clinically important changes in safety laboratory tests and vital signs will also be presented.
Time frame
12 monthsSecondary outcomes
1
Best tumor response in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).
Tumors will be assessed at screening, and tumor response will be assessed by the Investigator after Cycle 2 (± 1 week) has been completed and at the end of treatment (EOT) visit by positron emission tomography (PET)/computed tomography (CT) in accordance with LYRIC.
Time frame
12 MonthsSponsors and contacts
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Source ClinicalTrials.gov