Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma

ConditionNon Hodgkin's Lymphoma Refractory/Relapsed

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

N803
Drug
nogapendekin alfa inbakicept (also known as ALT-803; recombinant human superagonist interleukin-15 (IL-15) complex \[also known as IL 15N72D:IL-15RαSu/IgG1 Fc complex\])
CD19t-haNK suspension
Biological/Vaccine
Derived 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).
Cyclophosphamide
Drug
Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. The chemical name for cyclophosphamide is 2-\[bis(2-chloroethyl)amino\]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate and has the molecular formula C7H15Cl2N2O2P•H2O and a molecular weight of 279.1.
Fludarabine
Drug
Fludarabine phosphate is a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-β-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono β-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C10H13FN5O7P and it has a molecular weight of 365.2.
Rituximab
Drug
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

20 Participants

are divided into 2 treatment groups

Group A: Arm AExperimental treatment 4 interventions

Group B: Arm BExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

Primary Outcome Measures

Safety of CD19 t-haNK will be assessed by incidence and severity of TEAEs and SAEs, as well as incidence of clinically significant in safety laboratory tests and vital signs

Time frame

within 30 days after each cell infusion

Secondary outcomes

Secondary Outcome measures

Overall response rate (ORR) will be assessed in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) from first CD19 t-haNK infusion to death of last follow-up

Time frame

Within 12 months after first cell infusion

Other outcomes

Progression-free survival (PFS) after infusion in accordance with LYRIC

refers to the time from cell infusion to the first assessment of tumor progression or recurrence or death or last follow-up

Time frame

Within 12 months after first cell infusion

Duration of response (DoR) in accordance with LYRIC

Refers to the time from the first assessment of CR or PR to the first assessment of disease progression or death or last follow-up

Time frame

Within 12 months after first cell infusion

Overall survival (OS) after infusion

Refers to the time from cell infusion to death or last follow-up

Time frame

Within 12 months after first cell infusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ImmunityBio, Inc.

Lead sponsor

Source ClinicalTrials.gov

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