Study of Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma

ConditionRelapsed B-Cell Non Hodgkin Lymphoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorImmunityBio, Inc.

About this trial

Open Label, Phase 2 Study of CD19 t-haNK and N-803 in Combination with Rituximab in subjects with Relapsed/ Refractory B-cell Non- Hodgkin Lymphoma. 40 Participant will be screened for 20 subjects enrollment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have completed ≥2 lines of cytotoxic chemotherapy.

Have received rituximab or another anti-CD20 antibody.

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 involvement that is biopsy proven.

Disqualifiers

Histologically documented primary CNS lymphoma, CLL, Burkitt, Burkitt-like lymphoma.

Known hypersensitivity or allergy to any component of the study medications, including sulfa-containing study medication(s) (e.g., albumin [human], dimethyl sulfoxide [DMSO]).

ANC < 1000 cells/mm3.

Platelet count < 100,000 cells/mm3.

Trial design

Design model

Single group

Treatments tested in this trial

CD19 t-haNK- IV Administration
Biological/Vaccine
N-803 Subcutaneous (SQ): N-803 is a novel IL-15 superagonist immunotherapy administered subcutaneously. It is designed to enhance the proliferation and activation of natural killer (NK) cells and CD8+ T cells without stimulating regulatory T cells. N-803 SQ differs from other cytokine therapies due to its improved pharmacokinetic profile, enhanced in vivo activity, and reduced toxicity. CD19-Directed Therapies: CD19-targeted therapies, are biologic agents specifically designed to recognize and eliminate CD19-expressing B-cell malignancies. These therapies differ from traditional chemotherapy or small molecule inhibitors by leveraging the patient's immune system to achieve targeted cytotoxicity. Their mechanism of action involves direct binding to the CD19 antigen on malignant B cells, leading to immune-mediated cell death.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Open Label- Single ArmOther 1 intervention

Trial outcomes

Primary outcomes

Primary Endpoints( Efficacy)

ORR in accordance with Lymphoma Response to Immunomodulatory Therapy Criteria(LYRIC). OS( Time from study treatment initiation to death)

Time frame

6 months

Secondary outcomes

Secondary endpoints( Safety)

Incidence of treatment- emergent adverse events( TEAEs) and serious adverse event(SAEs) graded using the National Cancer Institute( NCI) CTCAE Version 5.0, Clinically important changes in laboratory.

Time frame

2 years

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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